Trabecular Metal® 6202-52-20Recalls & reported problems
Zimmer, Inc. · Class 2 · Implant
All models of Trabecular Metal (74)
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 4
- Deaths reported
- 0
- Injuries reported
- 3
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 00889024118867), received between Nov 24, 2021 and Nov 13, 2025 — classified as 3 injuries, 1 malfunction.
The most frequently reported specific device problem is “Loosening of Implant Not Related to Bone-Ingrowth” (2 reports).
3 other recalls cover devices cleared under the same FDA submission (K021891, K093561); they may or may not involve this specific model.
Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. What reports can and can't tell you · How this data works · Data updated Oct 18, 2026.
Reports received per month
Most reported problems
Device problems
- Loosening of Implant Not Related to Bone-Ingrowth2
- Difficult to Insert1
- Malposition of Device1
- Unstable1
Patient problems
- Failure of Implant2
- Aseptic loosening1
- Joint Dislocation1
- No Clinical Signs, Symptoms or Conditions1
- Osteopenia/ Osteoporosis1
- Unspecified Infection1
Recent adverse event reports
The 4 most recent of 4 reports, in the reporter's own words as published by the FDA.
InjuryNov 13, 2025Loosening of Implant Not Related to Bone-Ingrowth; Loosening of Implant Not Related to Bone-Ingrowth
IT WAS REPORTED THAT THE PATIENT UNDERWENT A HIP REVISION DUE TO RECURRENT DISLOCATION AND CUP LOOSENING. THE G7 OSSEOTI MULTI HOLE WAS REPLACED WITH A DUAL MOBILITY. IT WAS CONFIRMED THAT NO FURTHER INFORMATION COULD BE PROVIDED.
Patient problems: Aseptic loosening; Joint Dislocation
MAUDE report 23542027 ↗MalfunctionSep 2, 2025Difficult to Insert; Difficult to Insert
NO FURTHER INFORMATION AT THE TIME OF THIS REPORT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22937309 ↗InjuryDec 19, 2023Loosening of Implant Not Related to Bone-Ingrowth; Loosening of Implant Not Related to Bone-Ingrowth
NO FURTHER INFORMATION IS AVAILABLE AT THE TIME OF THIS REPORT.
Patient problems: Failure of Implant; Osteopenia/ Osteoporosis
MAUDE report 18354080 ↗InjuryNov 24, 2021Unstable; Malposition of Device; Unstable; Malposition of Device
IT WAS REPORTED THAT PATIENT UNDERWENT A HIP REVISION AFTER AN UNKNOWN AMOUNT OF TIME POST IMPLANTATION DUE TO ABNORMAL WEAR OF THE POLY LINER, INSTABILITY AND MALPOSITIONING OF THE DEVICES. THE LINER, CUP AND COMPETITORS HEAD WERE REMOVED AND REPLACED. ATTEMPTS HAVE BEEN MADE AND THE ADDITIONAL INFORMATION ON THE REPORTED EVENT IS UNAVAILABLE AT THIS TIME.
Patient problems: Failure of Implant; Unspecified Infection
MAUDE report 12870077 ↗
Recalls under the same FDA submission
These recalls involve devices cleared under K021891, K093561. One submission often covers many models, so check the product and lot details in each record.
- Z-1496-2014 · Apr 1, 2014 · TerminatedTRABECULAR METAL MODULAR ACETABULAR SYSTEM, Shell with Cluster Holes, Porous 60mm. Catalog number 00-6202-060-22; Hip implant component.
- Z-3279-2011 · Sep 1, 2011 · TerminatedThe Trabecular Metal Modular Acetabular System is a modular acetabular cup system consisting of a shell with a preassembled locking ring, a liner, and optional screws. The Shells
- Z-0060-2011 · Aug 18, 2010 · TerminatedZimmer Trabecular metal Modular Acetabular system 56 mm Porous shell with cluster holes, Catalog 00-6202-056-22, Zimmer Inc., Warsaw, IN. This device is indicated for primary or re
Other PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED devices
- PINNACLE 1217-25-500Depuy Orthopaedics, Inc. · PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED735 reports
- NA 1365-52-000Depuy (Ireland) · PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED683 reports
- APEX 1246-03-000Depuy (Ireland) · PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED3 deaths613 reports
- PINNACLE 1217-20-500Depuy Orthopaedics, Inc. · PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED2 deaths590 reports
- PINNACLE 1217-30-500Depuy Orthopaedics, Inc. · PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED1 death484 reports
- NA 1365-53-000Depuy (Ireland) · PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED404 reports
- PINNACLE ALTRX 1221-36-054Depuy Orthopaedics, Inc. · PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED388 reports
- PINNACLE ALTRX 1221-32-050Depuy Orthopaedics, Inc. · PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED386 reports
Sources and updates
- Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- Page last rebuilt: Oct 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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