Prosthesis, Hip, Hemi-, Femoral, Metal Ball
Orthopedic · 21 CFR 888.3360
Recent MDR events
1,120 adverse event reports on file
- UNK Hip Acetabular Metal HemiJul 27, 2026InjuryDepuy Orthopaedics Inc Us1818910-2026-12623
- TAPERED SPACER ARTICUL/EZE +0Jul 27, 2026InjuryDepuy Orthopaedics Inc Us1818910-2026-12697
- MODULAR CATHCART BALL 46MM ODJul 27, 2026InjuryDepuy Orthopaedics Inc Us1818910-2026-12698
- MODULAR CATHCART TAPERED SPACER 12/14 TAPER +5MMJul 15, 2026InjuryDepuy Orthopaedics Inc Us1818910-2026-11981
- MODULAR CATHCART FRACTURE HEAD HIP BALL 43MM OD +5MMJul 15, 2026InjuryDepuy Orthopaedics Inc Us1818910-2026-11982
- HEMI HIP IMPLANTJul 7, 2026InjuryDepuy Orthopaedics Inc Us1818910-2026-11558
- HEMI HIP IMPLANTJul 7, 2026InjuryDepuy Orthopaedics Inc Us1818910-2026-11560
- PROSTHESIS, HIP, HEMI-, FEMORAL, METAL BALLJul 6, 2026InjurySmith & Nephew, Inc.1020279-2026-00932
- MODULAR CATHCART BALL 43MM ODJun 30, 2026InjuryDepuy Orthopaedics Inc Us1818910-2026-11155
- TAPERED SPACER ARTICUL/EZE +0Jun 30, 2026InjuryDepuy Orthopaedics Inc Us1818910-2026-11157
Event type breakdown
Recalls
3 recall events for this product code
- BioPro, Inc.Open, ClassifiedOct 14, 2025
BioPro Endo Head (Ceramic)
Potential packaging issue that could compromise the sterile barrier. Defect may result in loss of sterility of the device, presenting potential risk of infection if device is implanted.
Z-0152-2026 · View FDA record ↗ - Smith & Nephew IncTerminatedSep 24, 2009
Tandem Unipolar, 46 MM CO-CR, REF 126646, Sterile, Smith & Nephew, Memphis TX 38116
46 mm Femoral head was mismarked and packaged as being 45 mm
Z-2314-2009 · View FDA record ↗ - DePuy Orthopaedics, Inc.Open, ClassifiedUnknown
MODULAR CATHCART FRACTURE HEAD HIP BALL, sizes 41mm to 60mm inclusive; metallic femoral head prosthesis, Product No. 136341000, 136342000, 136343000, 136344000,
The Cathcart Ball has an inherent +5mm offset which is not currently specified in its Instructions for Use or Surgical Technique Guide. The STG has been updated to reflect the clarification that the +5mm offset should be taken into consideration when using a Cathcart head in a construct for hemi-hip arthroplasty procedures.
Z-1375-2022 · View FDA record ↗
Registered firms
124 firms currently registered for this product code
Biopro, Inc.
PORT HURON, MI, US
Arch Medical Solutions - Memphis
Lexington, TN, US
Isomedix Operations, Inc.
Libertyville, IL, US
Shanghai Jpy Ion-tech Co., Ltd.
SHANGHAI, CN
Biomet Chile S.a.
Santiago de Chile Region Metropolitana, CL
Steris Schweiz Ag
Daniken Solothurn, CH
Medacta International Sa
Rancate Ticino, CH
Symmetry Medical Manufacturing Inc.
WARSAW, IN, US
Smith & Nephew Inc.
OKLAHOMA CITY, OK, US
Zimmer Biomet Pty Ltd
Sydney New South Wales, AU
Sterigenics U.s., Llc
Salt Lake City, UT, US
Medacta International Sa
Castel San Pietro Ticino, CH
Suzhou Elite Precision Machinery Co., Ltd.
Kunshan Jiangsu, CN
Johnson & Johnson Medical (depuy - Suzhou) Ltd.
SUZHOU Jiangsu, CN
Orchid Orthopedic Solutions Alabama Llc
Arab, AL, US
Depuy (ireland)
CO. CORK Munster, IE
Symmetry Medical Manufacturing Inc
CLAYPOOL, IN, US
Smith & Nephew, Inc.
MEMPHIS, TN, US
Zimmer Biomet G.k.
Hiratsuka Kanagawa, JP
Sterigenics Us Llc
West Memphis, AR, US
510(k) clearances
8 clearances for this product code
- Smith & Nephew, Inc.Jul 19, 2023
K231448 · TANDEM Hip System
- Medacta InternationalAug 16, 2011
K111145 · ENDO HEAD
- P.T. Latexindo TobaperkasaJan 5, 1998
K974442 · PRE-POWDERED NITRILE EXAMINATION GLOVES
- Implantology Corp.Jun 29, 1993
K915528 · BHR BIPOLAR FEMORAL HEAD COMPONENT
- Biomet, Inc.Mar 10, 1992
K915548 · IONGUARD TITANIUM MODULAR HEADS
- Depuy, Inc.Oct 3, 1990
K903084 · MODULAR CATHCART FRACTURE SYSTEM
- Richards Medical Co., Inc.Feb 15, 1990
K896580 · UNI-POLAR HEAD
- Protek, Inc.Jul 19, 1989
K892059 · FEMORAL HEADS/MODULAR & FIXED W/ TITAN NITRIDE SUR