Prosthesis, Hip, Semi-constrained, Uncemented, Metal/polymer, Porous
Orthopedic · 21 CFR 888.3358
Recent MDR events
1,004 adverse event reports on file
- Dynasty Biofoam ShellsJul 27, 2026InjuryMicroport Orthopedics Inc.3010536692-2026-00250
- Prosthesis, Hip, Semi-Constrained, Uncemented, Metal/Polymer, PorousJul 27, 2026InjurySmith & Nephew, Inc.1020279-2026-01029
- R3 MULTI HOLE ACETABULAR SHELL 54MMJul 20, 2026InjurySmith & Nephew, Inc.1020279-2026-00989
- PROSTHESIS, HIP, SEMI-CONSTRAINED, UNCEMENTED, METAL/POLYMER, POROUSJul 17, 2026InjurySmith & Nephew, Inc.1020279-2026-00974
- PROSTHESIS, HIP, SEMI-CONSTRAINED, UNCEMENTED, METAL/POLYMER, POROUSJul 16, 2026InjurySmith & Nephew, Inc.1020279-2026-00969
- UNKN ORTHOPAEDIC RECONSTRUCTION DEVJul 14, 2026InjurySmith & Nephew, Inc.1020279-2026-00955
- PROSTHESIS, HIP, SEMI-CONSTRAINED, UNCEMENTED, METAL/POLYMER, POROUSJul 2, 2026InjurySmith & Nephew, Inc.1020279-2026-00911
- R3 3 HOLE HA CTD ACET SHELL 52MMJun 22, 2026MalfunctionSmith & Nephew, Inc.1020279-2026-00860
- R3 3 HOLE HA CTD ACET SHELL 46MMJun 15, 2026InjurySmith & Nephew, Inc.1020279-2026-00831
- DELTA PF CUPJun 11, 2026MalfunctionLimacorporate S.p.a.3008021110-2026-00251
Event type breakdown
Recalls
12 recall events for this product code
- MicroPort Orthopedics, Inc.TerminatedSep 28, 2015
PROFEMUR PLUS CoCr MODULAR NECK, REF: PHAC1254, SIZE LONG, ORIENTATION 8 degree VAR/VAL. 12/14 SLT Taper.
Unexpected rate of postoperative fractures resulting in the need for revision surgery.
Z-2743-2015 · View FDA record ↗ - Smith & Nephew IncTerminatedFeb 21, 2014
Reflection Interfit Shell, 52 MM OD, 3 HOLE, REF 71336052, QTY 1, STERILE R, Smith & Nephew, Inc.
Inner spherical radius of the shell is undersized.
Z-1066-2014 · View FDA record ↗ - Smith & Nephew IncTerminatedAug 8, 2013
R3 (TM) XLPE ACETABULAR LINER UHMWPE, 20o OVERHANG, 36 MM ID, 62 MM OD, QTY: (1), STERILE H2O2, REF 71335762.
One batch of 60 mm 20o R3 XLPE liner may be laser etched and packaged as a 62 mm 20o liner and one batch of 62 mm 20o R3 XLPE liner may be laser etched and packaged as a 60 mm 20o liner.
Z-1928-2013 · View FDA record ↗ - Smith & Nephew IncTerminatedAug 8, 2013
R3 (TM) XLPE ACETABULAR LINER UHMWPE, 20o OVERHANG, 36 MM ID, 60 MM OD, QTY: (1), STERILE H2O2, REF 71335760.
One batch of 60 mm 20o R3 XLPE liner may be laser etched and packaged as a 62 mm 20o liner and one batch of 62 mm 20o R3 XLPE liner may be laser etched and packaged as a 60 mm 20o liner.
Z-1929-2013 · View FDA record ↗ - Ortho Development CorporationTerminatedJun 20, 2011
Encompass Hip Stem, Plasma Spray, 12/14 Taper, Standard, REF 108-XXXX, Sterile R, Ortho Development, Draper, Utah 84020.
Tests on PVC packaging material resulted in alert levels for cytotoxicity.
Z-2602-2011 · View FDA record ↗ - Ortho Development CorporationTerminatedJun 20, 2011
Encompass Hip Stem, Plasma Spray, 12/14 Taper, Extended, REF 109-XXXX, Sterile R, Ortho Development, Draper, Utah 84020.
Tests on PVC packaging material resulted in alert levels for cytotoxicity.
Z-2603-2011 · View FDA record ↗ - Smith & Nephew, Inc.Open, ClassifiedUnknown
smith&nephew R3 NO HOLE HEMISPHERICAL STIKTITE COATED SHELL, manufactured in the following sizes:
A manufacturing error resulted in out of specification R3 Acetabular Shells
Z-2331-2020 · View FDA record ↗ - Smith & Nephew, Inc.Open, ClassifiedUnknown
smith&nephew R3 ZERO HOLE HA COATED HEMISPHERICAL STIKTITE COATED SHELL, manufactured in the following sizes:
A manufacturing error resulted in out of specification R3 Acetabular Shells
Z-2332-2020 · View FDA record ↗ - Smith & Nephew, Inc.Open, ClassifiedUnknown
smith&nephew R3 THREE HOLE HEMISPHERICAL STIKTITE COATED SHELL, manufactured in the following sizes:
A manufacturing error resulted in out of specification R3 Acetabular Shells
Z-2333-2020 · View FDA record ↗ - Smith & Nephew, Inc.Open, ClassifiedUnknown
smith&nephew R3 THREE HOLE HA COATED HEMISPHERICAL STIKTITE COATED SHELL, manufactured in the following sizes:
A manufacturing error resulted in out of specification R3 Acetabular Shells
Z-2334-2020 · View FDA record ↗
Registered firms
407 firms currently registered for this product code
Limacorporate S.p.a.
Calatafimi Segesta (TP) Sicilia, IT
Sterigenics U.s., Llc
Atlanta, GA, US
Isomedix Operations Inc.
Sandy, UT, US
Orchid Orthopedics-chelsea
Chelsea, MI, US
Arch Medical Solutions - Memphis
Lexington, TN, US
Isomedix Operations Inc.
Northborough, MA, US
Isomedix Operations, Inc.
Minneapolis, MN, US
Ceramtec Gmbh Medical Products Division
PLOCHINGEN Baden-Wurttemberg, DE
Lincotek Bologna S.r.l.
Cadriano di Granarolo, Bologna, IT
Limacorporate S.p.a.
Villanova di San Daniele Udine, IT
Lsm-med S.r.l.
Serravalle San Marino Citta, SM
Zimmer Biomet Taiwan Co., Ltd.
Taipei, TW
Hpf S.r.l.
Forgaria nel Friuli Friuli-Venezia Giulia, IT
Smith & Nephew, Inc.
Memphis, TN, US
Isomedix Operations, Inc.
Libertyville, IL, US
Straits Orthopaedics (mfg) Sdn Bhd
Perai Pulau Pinang, MY
Arvato Usa Llc
Memphis, TN, US
Howmedica Osteonics Corp
MAHWAH, NJ, US
Adler Ortho S.p.a.
Cormano Milano, IT
Biomet, Inc.
WARSAW, IN, US
T & L Sharpening, Inc.
Indiana Beach, IN, US
510(k) clearances
13 clearances for this product code
- Microport Orthopedics, Inc.Aug 24, 2021
K201157 · Prime BIOFOAM® Multi-Hole Shells
- Smith & Nephew, Inc.Oct 6, 2020
K201701 · R3 HA Coated Acetabular Shells
- Smith & Nephew, Inc.Nov 19, 2018
K182535 · R3 Anteverted Liners
- Smith & Nephew, Inc.Dec 14, 2016
K161233 · OXINIUM DH Fermoral Heads
- WrightmedicaltechnologyincOct 22, 2012
K122382 · DYNASTY BIOFOAM SHELL
- Smith & Nephew, Inc.Apr 27, 2012
K113848 · R3 XLPE LINERS
- Smith & Nephew, Inc.Jan 19, 2011
K102370 · R3 XLPE ANTEVERTED LINERS
- Smith & Nephew, Inc.Jan 26, 2010
K093363 · COCR AND OXINIUM FEMORAL HEADS AND R3 XLPE LINERS