Exactech 142-32-00Recalls & reported problems
Exactech, Inc. · Class 2 · Implant
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 2
- Deaths reported
- 0
- Injuries reported
- 2
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 10885862026835), received between Jul 9, 2024 and Jul 15, 2024 — classified as 2 injuries.
The most frequently reported specific device problem is “Naturally Worn” (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.
Reports received per month
Most reported problems
Device problems
- Adverse Event Without Identified Device or Use Problem1
- Naturally Worn1
Patient problems
- Osteolysis2
- Pain1
- Synovitis1
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
InjuryJul 15, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
AS REPORTED, THE MALE PATIENT HAD HIS LEFT POLY INSERT AND FEMORAL HEAD REVISED DUE TO SIGNS OF OSTEOLYSIS. THE FEMUR WAS DISLOCATED, THE COCR FEMORAL HEAD REMOVED, STEM WAS WELL FIXED, TURNED TO THE CUP AND REMOVED THE LINER. AFTER ATTEMPTS TO REMOVE WITH OSTEOTOME, A BONE SCREW WAS PLACED TO REMOVE THE LINER. THE CUP WAS WELL FIXED, AND THE PATIENT RECEIVED A NEW G2 LIPPED E POLY AND A NEW BIOLOX HEAD. THEIR LEFT HIP WAS REVISED APPROXIMATELY 7 YEARS 3 MONTHS AFTER THEIR INITIAL IMPLANTATION. PATIENT WAS LAST KNOWN TO BE IN STABLE CONDITION FOLLOWING THE EVENT. THERE IS NO ADDITIONAL INFORMATION AVAILABLE.
Patient problems: Osteolysis; Pain
MAUDE report 19741751 ↗InjuryJul 9, 2024Naturally Worn; Naturally Worn
IT WAS REPORTED THAT APPROXIMATELY 52 MONTHS AFTER A RIGHT TOTAL HIP REPLACEMENT PROCEDURE, THE PATIENT UNDERWENT A REVISION PROCEDURE TO ADDRESS PROSTHESIS WEAR, MILD OSTEOLYSIS, WEAR DEBRIS, INFLAMMATORY SYNOVIUM. REVISION SURGERY OPERATIVE NOTES WERE PROVIDED. PATIENT LEFT THE OPERATING ROOM IN STABLE CONDITION. POST OPERATIVE DIAGNOSIS NOTED WEAR OF THE IMPLANT. NO FURTHER ISSUES OR COMPLICATIONS WERE REPORTED. NO ADDITIONAL INFORMATION IS AVAILABLE.
Patient problems: Osteolysis; Synovitis
MAUDE report 19704762 ↗
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, ClassifiedGXL 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
Other Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, Uncemented devices
- BIOLOX DELTA 1365-32-310Depuy Orthopaedics, Inc. · Prosthesis, hip, semi-constrained, metal/ceramic/polymer, cemented or non-porous, uncemented551 reports
- PINNACLE ALTRX 1221-36-052Depuy Orthopaedics, Inc. · Prosthesis, hip, semi-constrained, metal/ceramic/polymer, cemented or non-porous, uncemented481 reports
- BIOLOX DELTA 1365-32-320Depuy Orthopaedics, Inc. · Prosthesis, hip, semi-constrained, metal/ceramic/polymer, cemented or non-porous, uncemented1 death314 reports
- BIOLOX DELTA 1365-36-720Depuy Orthopaedics, Inc. · Prosthesis, hip, semi-constrained, metal/ceramic/polymer, cemented or non-porous, uncemented1 death189 reports
- DJO SURGICAL 400-03-362Encore Medical, L.P. · Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, Uncemented187 reports
- Anthology 71365705Smith & Nephew, Inc. · Prosthesis, hip, semi-constrained, metal/ceramic/polymer, cemented or non-porous, uncemented176 reports
- BIOLOX DELTA 1365-40-710Depuy Orthopaedics, Inc. · Prosthesis, hip, semi-constrained, metal/ceramic/polymer, cemented or non-porous, uncemented170 reports
- PINNACLE GRIPTION 1217-32-054Depuy Orthopaedics, Inc. · Prosthesis, hip, semi-constrained, metal/ceramic/polymer, cemented or non-porous, uncemented169 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 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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