CoCr HeadRecalls & reported problems across all models
Zimmer GmbH · 3 models in the FDA device registry
Data updated Oct 16, 2026 from official FDA records · Editorial policy
1 open recall names at least one CoCr Head model. Check whether yours is affected in the recall details, and contact the manufacturer or your healthcare provider.
- Adverse event reports
- 2
- Deaths reported
- 0
- Injuries reported
- 2
- Recalls
- 1
We found 3 models of CoCr Head by Zimmer GmbH in the FDA's device registry (GUDID). Together they are named in 2 adverse event reports in the FDA's MAUDE database, received between Aug 12, 2020 and Nov 14, 2023 — classified as 2 injuries.
The most frequently reported specific device problem is “Device Dislodged or Dislocated” (1 report).
1 FDA recall record name at least one of these models by its device identifier, 1 still open.
Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event. Widely used products collect more reports, so totals can't be used to compare products or estimate failure rates. Only reports that name a model's exact device identifier are counted. What reports can and can't tell you · How this data works
Reports received per month, all models
CoCr Head recalls
FDA recall records that name at least one of these models by its device identifier, newest first. Each recall usually covers specific models or lots, so check the details.
- Feb 27, 2023Open, Classified
Update the compatibility matrix as referred to in the Instructions for Use (IFU) for the CoCr Femoral Head XS- removes the compatibility with the Epsilon Durasul Constrained Acetabular Liners from the matrix due to the range of motion in flexion/extension being less than 100 degrees as recommended per an internationally recognized standard (ISO 21535:2009
Z-1294-2023 · Root cause: Under Investigation by firm · Recall details · FDA record ↗
Most reported CoCr Head problems
Device problems
- Adverse Event Without Identified Device or Use Problem1
- Device Dislodged or Dislocated1
Patient problems
- Ambulation or Postural Difficulties1
- Joint Dislocation1
- No Known Impact Or Consequence To Patient1
- Pain1
CoCr Head models
3 models, most reported first. Each model has its own page with its reports, recalls and device details.
- CoCr Head 01.01012.384Prosthesis, hip, semi-constrained, metal/polymer, cemented1 recall0 reports
- CoCr Head 01.01012.387Prosthesis, hip, semi-constrained, metal/polymer, cemented1 report
- CoCr Head 01.01012.388Prosthesis, hip, semi-constrained, metal/polymer, cemented1 report
Recent CoCr Head adverse event reports
The 2 most recent reports across all models, in the reporter's own words as published by the FDA.
InjuryNov 14, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED APPROXIMATELY SIX (6) YEARS POST IMPLANTATION, THE PATIENT IS EXPERIENCING HIGH LEVELS OF PAIN AND DIFFICULTY AMBULATING. NO REVISION HAS BEEN SCHEDULED TO DATE. ATTEMPTS HAVE BEEN MADE AND NO FURTHER INFORMATION IS AVAILABLE.
Patient problems: Ambulation or Postural Difficulties; Pain
MAUDE report 18135020 ↗InjuryAug 12, 2020Device Dislodged or Dislocated; Device Dislodged or Dislocated
NO CHANGE TO PREVIOUSLY REPORTED EVENT.
Patient problems: Joint Dislocation; No Known Impact Or Consequence To Patient
MAUDE report 10394713 ↗
Other Zimmer GmbH products
- Affixus Natural Nail55 models · 612 reports
- Biolox delta16 models · 343 reports
- NCB78 models · 200 reports
- Zimmer Natural Nail System57 models · 187 reports
- Biolox Option16 models · 68 reports · 2 recalls
- Avenir24 models · 57 reports · 1 recall
- Anatomical Shoulder33 models · 102 reports
- Sidus Stem-Free Shoulder9 models · 30 reports · 1 recall
Sources and updates
- Models: FDA GUDID, file dated Oct 13, 2026. Models are grouped by the brand name the manufacturer registered.
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- Page last rebuilt: Oct 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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