Acumatch L-SeriesRecalls & reported problems across all models

We found 9 models of Acumatch L-Series by Exactech, Inc. in the FDA's device registry (GUDID). Together they are named in 3 adverse event reports in the FDA's MAUDE database, received between Oct 15, 2019 and Feb 12, 2025 — classified as 3 injuries.

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

Acumatch L-Series 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.

1. Apr 26, 2024Open, Classified

   The AcuMatch L-Series 22mm Inner Diameter Bipolar Hip Liner lots were packaged without the specified ethylene vinyl alcohol (EVOH) layer. Between 2004 and August 2021, our packaging process utilized two different types of packaging materials: 1) Low Density Polyethylene (LDPE), Nylon, and EVOH, or 2) LDPE and Nylon without EVOH.

   Z-2236-2024 · Root cause: Other · names 6 of these models · Recall details · FDA record ↗

Most reported Acumatch L-Series problems

Acumatch L-Series models

9 models, most reported first. Each model has its own page with its reports, recalls and device details.

• Acumatch L-Series 100-22-19

  Prosthesis, Hip, Hemi-, Femoral, Metal/Polymer, Cemented Or Uncemented
  1 recall0 reports
• Acumatch L-Series 100-22-20

  Prosthesis, Hip, Hemi-, Femoral, Metal/Polymer, Cemented Or Uncemented
  1 recall0 reports
• Acumatch L-Series 100-22-21

  Prosthesis, Hip, Hemi-, Femoral, Metal/Polymer, Cemented Or Uncemented
  1 recall0 reports
• Acumatch L-Series 100-22-22

  Prosthesis, Hip, Hemi-, Femoral, Metal/Polymer, Cemented Or Uncemented
  1 recall0 reports
• Acumatch L-Series 100-22-23

  Prosthesis, Hip, Hemi-, Femoral, Metal/Polymer, Cemented Or Uncemented
  1 recall0 reports
• Acumatch L-Series 100-22-24

  Prosthesis, Hip, Hemi-, Femoral, Metal/Polymer, Cemented Or Uncemented
  1 recall0 reports
• Acumatch L-Series BP-2844

  Prosthesis, Hip, Hemi-, Femoral, Metal/Polymer, Cemented Or Uncemented
  1 report
• Acumatch L-Series BP-2850

  Prosthesis, Hip, Hemi-, Femoral, Metal/Polymer, Cemented Or Uncemented
  1 report
• Acumatch L-Series BP-2853

  Prosthesis, Hip, Hemi-, Femoral, Metal/Polymer, Cemented Or Uncemented
  1 report

Recent Acumatch L-Series adverse event reports

The 3 most recent reports across all models, in the reporter's own words as published by the FDA.

• 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 21364026 ↗
• InjuryJan 15, 2020Naturally Worn; Naturally Worn

  AS REPORTED, THIS (B)(6) Y/O ACTIVE FEMALE EXPERIENCED A IMPLANTATION OF THE FEMORAL HEAD REPLACEMENT FOR LEFT FEMORAL NECK FRACTURE WAS PERFORMED USING NOVATION TAPERED STEM, BIPOLAR CUP, AND METAL HEAD ON (B)(6) 2014. THE PATIENT IS NOW UNDERGOING A RIGHT TOTAL HIP ARTHROPLASTY REVISION DUE TO PROXIMAL MIGRATION OF THE BIPOLAR CUP WAS OBSERVED BY X-RAY REVIEW. THE PROCEDURE WAS ON (B)(6) 2019 AT POST-OPERATIVE 5-YEARS AND 9-MONTHS. AT THE TIME OF THE RE-OPERATION, THE BIPOLAR CUP AND THE METAL HEAD WAS REMOVED BUT A REMARKABLE DELAMINATION WEAR THAT MIGHT BE CAUSED BY OXIDATION WAS OBSERVED AROUND THE LOCKING RING OF THE POLYETHYLENE BIPOLAR LINER. PATIENT¿S WEIGHT (B)(6) LBS, HEIGHT 4¿7¿. DEVICES ARE TO BE RETURNED FOR INVESTIGATION.

  Patient problems: Failure of Implant

  MAUDE report 9591528 ↗
• InjuryOct 15, 2019Adverse Event Without Identified Device or Use Problem

  REVISION OF A BIPOLAR HEAD DUE TO THE PATIENT WAS SUPER ACTIVE AND FRACTURED THEIR PELVIS. THE PATIENT WAS STABLE AS THEY LEFT THE OPERATING ROOM AND THIS DID NOT CAUSE A DELAY. IN ACCORDANCE WITH HOSPITAL POLICY WE ARE UNABLE TO RETURN THE EXPLANTS. NO OTHER INFORMATION AVAILABLE AT THIS TIME. UPON REVIEW OF THE AVAILABLE INFORMATION, THERE IS NO EVIDENCE THAT THIS IS A DEVICE RELATED PROBLEM AND THERE IS NO ALLEGATION AGAINST THE DEVICE. THE MOST LIKELY CAUSE FOR THE BONE FRACTURE WAS THE PATIENT¿S ACTIVITY.

  Patient problems: Bone Fracture(s)

  MAUDE report 9195304 ↗

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