Exactech 142-28-00Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 10885862026774), received between Oct 14, 2020 and Mar 7, 2025 — classified as 4 injuries.

The most frequently reported specific device problem is “Detachment of Device or Device Component” (1 report).

1 other recall cover devices cleared under the same FDA submission (K041906); 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 16, 2026.

Most reported problems

Recent adverse event reports

The 4 most recent of 4 reports, in the reporter's own words as published by the FDA.

• InjuryMar 7, 2025Naturally Worn; Naturally Worn

  IT WAS REPORTED VIA LEGAL DOCUMENTATION THAT APPROXIMATELY 41 MONTHS AFTER A RIGHT TOTAL HIP REPLACEMENT PROCEDURE, THE PATIENT UNDERWENT A REVISION PROCEDURE TO ADDRESS ECCENTRIC POLYETHYLENE WEAR AND OSTEOLYSIS. INITIAL SURGERY AND REVISION SURGERY OPERATIVE NOTES WERE PROVIDED. FINDINGS INDICATED EXTREME SYNOVITIS AND METALLOSIS, AND THE SURGEON WAS ABLE TO REMOVE THE CUP WITH HIS FINGERS. THE SURGEON PERFORMED A REVISION OF THE ACETABULAR CUP/LINER AND FEMORAL HEAD. PATIENT WAS TAKEN BACK TO THE POSTANESTHESIA RECOVERY ROOM IN A STABLE FASHION. NO FURTHER ISSUES OR COMPLICATIONS WERE REPORTED. NO ADDITIONAL INFORMATION IS AVAILABLE.

  Patient problems: Implant Pain; Metal Related Pathology; Osteolysis; Synovitis

  MAUDE report 21549384 ↗
• InjuryFeb 12, 2025Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED THAT THIS PATIENT'S HIP WAS REVISED APPROXIMATELY 3.5 YEARS POST INITIAL OPERATION. THE PATIENT FELL DOWN AND HAD DISLOCATION OF BIPOLAR CUP. NEXT DAY, THIS PATIENT WENT TO SEE A DOCTOR AND SURGEON FOUND OUT DISASSOCIATION OF FEMORAL HEAD FROM BIPOLAR CUP VIA IMAGING SYSTEM WHEN HE PERFORMED A CLOSED/MANUAL REDUCTION BY USING IMAGING SYSTEM. IN THIS SITUATION, HE DECIDED TO PERFORM REVISION SURGERY AND FEMORAL HEAD AND BIPOLAR CUP WERE REPLACED TO NEW ONES. THIS FEMORAL HEAD CAME OFF THIS BIPOLAR CUP WITHOUT DISASSOCIATION OF LOCKING RING.

  Patient problems: Fall; Joint Dislocation

  MAUDE report 21364024 ↗
• InjuryFeb 6, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  AS REPORTED, APPROXIMATELY 44 DAYS POST INITIAL LEFT SIDE THA, THE FEMALE PATIENT WAS BROUGHT BACK FOR A DISLOCATED LEFT BIPOLAR HIP. THE BIPOLAR SHELL AND 28 HEAD WERE REMOVED. THE STEM CHECKED AND FOUND TO BE WELL FIXED. A COMPETITOR'S DUAL MOBILITY CUP AND AN EXACTECH 28 +3.5 HEAD WAS THEN IMPLANTED. THERE WAS NO BREAKAGE OF DEVICE OR SURGICAL DELAY/PROLONGATION. PATIENT WAS LAST KNOWN TO BE IN STABLE CONDITION FOLLOWING THE EVENT. PHOTO RECEIVED. SALES REP WAS UNABLE TO OBTAIN X-RAYS. THE DEVICE IS NOT AVAILABLE FOR EVALUATION AS IT WAS DISCARDED BY HOSPITAL. NO OTHER PATIENT INFORMATION/MEDICAL HISTORY REPORTED.

  Patient problems: Joint Dislocation

  MAUDE report 16308514 ↗
• InjuryOct 14, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ON (B)(6) 2000,14 DAYS POST-OP, A LEFT HIP DISLOCATION OF THE BIPOLAR CUP FROM THE INNER HEAD FIXED TO FEMORAL STEM WAS OBSERVED WHEN THE POST-OP X-RAYS OF THE PATIENT WAS TAKEN. REVISION SURGERY OF THE BIPOLAR CUP AND THE INNER HEAD WAS IMMEDIATELY PERFORMED. THE DISLOCATED BIPOLAR CUP OF DIA. 54MM AND THE DIA. 28MM+0MM INNER METAL HEAD WERE WELL FIXED TO FEMORAL STEM AND WERE REMOVED. REPLACED TO BIPOLAR CUP OF DIA. 53MM AND DIA. 28MM + 3.5MM INNER HEAD. THE LOCKING RING OF THE RETRIEVED BIPOLAR CUP WAS FIRMLY ASSEMBLED TO THE METALLIC SHELL AND ANY DAMAGES OF THE POLYETHYLENE LOCKING RING WAS NOT OBSERVED VISUALLY AT ALL. THERE WAS A 30-45 MIN DELAY IN SURGERY, (NOTE: THIS SURGICAL DELAY MEANS THE SURGICAL TIME OF THIS REVISION SURGERY COMPARED AGAINST THE SURGICAL TIME OF THE PRIMARY SURGERY. THE ACTUAL PRIMARY AND REVISION SURGERY HAVE BEEN SMOOTHLY FINISHED.) THIS DID NOT CAUSE ANY ADVERSE EVENT TO THE PATIENT. PATIENT CONTINUES IN FOLLOW-UP. DEVICES WILL RETURN.

  Patient problems: Joint Dislocation

  MAUDE report 10677366 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K041906. One submission often covers many models, so check the product and lot details in each record.

• Z-1727-2022 · Aug 11, 2022 · Open, Classified
  GXL acetabular liners, orthopedic hip implant component. Product Line Numbers: a. ACUMATCH +5MM LAT LINER 15 DEG 36MM ID, SIZE H, REF 138-36-08 b. ACUMATCH +5MM LAT LINER 15 DE