Prosthesis, Hip, Constrained, Cemented Or Uncemented, Metal/polymer
Orthopedic · 21 CFR 888.3310
Recent MDR events
5,676 adverse event reports on file
- PINNACLEJul 27, 2026InjuryDepuy Orthopaedics Inc Us1818910-2026-12691
- PINNACLEJul 27, 2026InjuryDepuy Orthopaedics Inc Us1818910-2026-12694
- PINNACLEJul 27, 2026InjuryDepuy Orthopaedics Inc Us1818910-2026-12712
- PINNACLEJul 27, 2026InjuryDepuy Orthopaedics Inc Us1818910-2026-12775
- PINNACLEJul 20, 2026InjuryDepuy Orthopaedics Inc Us1818910-2026-12262
- UNKNOWN G7 INSERTERJul 13, 2026MalfunctionZimmer Biomet, Inc.0001825034-2026-02047
- PINNACLEJul 10, 2026InjuryDepuy Orthopaedics Inc Us1818910-2026-11742
- PINNACLEJul 10, 2026InjuryDepuy Orthopaedics Inc Us1818910-2026-11768
- PINNACLEJul 10, 2026InjuryDepuy Orthopaedics Inc Us1818910-2026-11833
- PINNACLEJul 8, 2026InjuryDepuy Orthopaedics Inc Us1818910-2026-11590
Event type breakdown
Recalls
19 recall events for this product code
- Exactech, Inc.Open, ClassifiedJan 18, 2024
Exactech Novation Hip System, Catalog Numbers: 134-36-45
Exactech has received 3 complaints for 4 devices related to a loss of vacuum in the inner-most vacuum bag.
Z-0581-2024 · View FDA record ↗ - Smith & Nephew, Inc.TerminatedJun 9, 2015
R3(TM) 22 MM I.D., 52 MM O.D. CONSTRAINED LINER, REF 71339152, QTY: (1), STERILE EO.
The R3 Constrained outer liner locking groove diameter is 0.030 inches oversized and may not allow the locking ring to engage into the R3 shell.
Z-1735-2015 · View FDA record ↗ - Smith & Nephew, Inc.TerminatedJun 9, 2015
R3(TM) 22 MM I.D., 56 MM O.D. CONSTRAINED LINER, REF 71339156, QTY: (1), STERILE EO.
The R3 Constrained outer liner locking groove diameter is 0.030 inches oversized and may not allow the locking ring to engage into the R3 shell.
Z-1736-2015 · View FDA record ↗ - Smith & Nephew, Inc.TerminatedJun 9, 2015
R3(TM) 22 MM I.D., 58 MM O.D. CONSTRAINED LINER, REF 71339158, QTY: (1), STERILE EO.
The R3 Constrained outer liner locking groove diameter is 0.030 inches oversized and may not allow the locking ring to engage into the R3 shell.
Z-1737-2015 · View FDA record ↗ - Smith & Nephew, Inc.TerminatedJun 9, 2015
R3(TM) 28 MM I.D., 60 MM O.D. CONSTRAINED LINER, REF 71339160, QTY: (1), STERILE EO,
The R3 Constrained outer liner locking groove diameter is 0.030 inches oversized and may not allow the locking ring to engage into the R3 shell.
Z-1738-2015 · View FDA record ↗ - Smith & Nephew, Inc.TerminatedJun 9, 2015
R3(TM) 28 MM I.D., 62 MM O.D. CONSTRAINED LINER, REF 71339162, QTY: (1), STERILE EO.
The R3 Constrained outer liner locking groove diameter is 0.030 inches oversized and may not allow the locking ring to engage into the R3 shell.
Z-1739-2015 · View FDA record ↗ - Zimmer, Inc.TerminatedNov 20, 2012
Trilogy II Constrained Liner
Trilogy Longevity Constrained Liner devices were packaged in incorrect cartons. The product is packaged in the incorrect carton. Product labels and patient labels are correct, matching the product inside the carton.
Z-0386-2013 · View FDA record ↗ - DePuy Orthopaedics, Inc.TerminatedSep 20, 2012
S-Rom Total Hip System Poly Liner
Orthopaedics, Inc. (DePuy) is issuing a voluntary recall of four lots of the S-ROM" liner because the Carton label has an Incorrect Color Code Series Designation. We have received one complaint regarding this issue.
Z-2414-2012 · View FDA record ↗ - Smith & Nephew IncTerminatedOct 18, 2010
R3 (TM) 22 MM I.D., 52 MM O.D., CONSTRAINED LINER, UHMWPE, CO-CR, TI-6AL-4V, REF 71339152, STERILE EO, QTY 1, Smith & Nephew, Inc., Hip prosthesis acetabular co
The firm received reports of a femoral head popping out of the liner intraoperatively.
Z-0079-2011 · View FDA record ↗ - Smith & Nephew IncTerminatedOct 18, 2010
R3 (TM) 22 MM I.D., 54 MM O.D., CONSTRAINED LINER, UHMWPE, CO-CR, TI-6AL-4V, REF 71339154, STERILE EO, QTY 1, Smith & Nephew, Inc., Hip prosthesis acetabular co
The firm received reports of a femoral head popping out of the liner intraoperatively.
Z-0080-2011 · View FDA record ↗
Registered firms
839 firms currently registered for this product code
Sct, Inc.
FRANKLIN LAKES, NJ, US
Ken-mar Machine Mfg Corp
Paterson, NJ, US
Zimmer Biomet Canada Dfe
Mississauga Ontario, CA
Zimmer (shanghai) Medical International Trading Co., Ltd.
Shanghai, CN
Biomet Global Supply Chain Center B.v.
Hazeldonk Noord-Brabant, NL
Orchid Orthopedics-chelsea
Chelsea, MI, US
Arch Medical Solutions - Memphis
Lexington, TN, US
Valtecne Spa
Berbenno di Valtellina Sondrio, IT
Isomedix Operations Inc.
Northborough, MA, US
Zimmer Biomet Korea Ltd.
Seoul, KR
Aps Materials Inc. Ireland
Waterford, IE
Zimmer Gmbh
WINTERTHUR Zurich, CH
Ionisos
Dagneux Ain, FR
Dot America, Inc.
Columbia City, IN, US
Sterigenics Us, Llc
Lewis Center, OH, US
Sterigenics U.s., Llc
Atlanta, GA, US
Lh Medical Corporation
Fort Wayne, IN, US
Isomedix Operations, Inc.
Libertyville, IL, US
Howmedica Osteonics Corp
MAHWAH, NJ, US
Zimmer, Inc.
WARSAW, IN, US
Zimmer Biomet Taiwan Co., Ltd.
Taipei, TW
510(k) clearances
34 clearances for this product code
- Medacta International S.A.Jul 31, 2025
K241461 · Mpact Constrained Liner
- Depuy Ireland UCApr 4, 2024
K240639 · PINNACLETM Constrained Acetabular Liners
- Smith & Nephew, Inc.Jun 19, 2017
K162641 · Smith & Nephew, Inc. R3 Constrained Liner
- Encore Medical L.P.Mar 2, 2017
K163497 · EXPRT Revision Hip System - EXPRT Hip Distal Stem, EXPRT Hip Standard Offset Proximal Body Implant, EXPRT Hip Lateral Offset Proximal Body Implant, EXPRT Hip Capture Bolt
- Encore Medical L.P.Nov 9, 2016
K161610 · EXPRT Revision Hip System
- Smith & Nephew, Inc.Oct 16, 2012
K122139 · SMITH & NEPHEW R3 CONSTRAINED LINERS
- Smith & Nephew, Inc.Sep 9, 2011
K111635 · SMITH & NEPHEW RJ CONSTRAINED LINERS
- Zimmer, Inc.Dec 3, 2010
K101730 · LONGEVITY IT HIGHLY CROSSLINKED POLYETHYLENE CONSTRAINED LINERS
PMA approvals
2 premarket approvals for this product code