Acumatch A Series 132-36-28Recalls & reported problems

Summary

The FDA's MAUDE database contains 7 adverse event reports that list this exact device (DI 10885862023391), received between Oct 29, 2019 and Aug 21, 2024 — classified as 7 injuries.

The most frequently reported specific device problem is “Naturally Worn” (6 reports).

2 FDA recall records name this device's identifier, 2 still open.

10 other recalls cover devices cleared under the same FDA submission (K051556); 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.

Recalls naming this device

1. Aug 11, 2022Class IIOpen, Classified

   Specific GXL acetabular polyethylene liners, packaged in non-conforming bags, may adversely impact the device and contribute to accelerated wear.

   Z-1728-2022 · Root cause: Process control · Recall details · FDA record ↗

2. Jun 29, 2021Class IIOpen, Classified

   Risk of edge-loading and premature prosthesis wear is possible in a specific subset of patients with certain implant configurations and surgical implant positioning.

   Z-2122-2021 · Root cause: Unknown/Undetermined by firm · Recall details · FDA record ↗

Most reported problems

Recent adverse event reports

The 7 most recent of 7 reports, in the reporter's own words as published by the FDA.

• InjuryAug 21, 2024Naturally Worn; Naturally Worn

  IT WAS REPORTED THAT APPROXIMATELY UNKNOWN MONTHS AFTER A LEFT TOTAL KNEE REPLACEMENT PROCEDURE, THE PATIENT HAS EXPERIENCED PROSTHESIS WEAR. NO FURTHER ISSUES OR COMPLICATIONS WERE REPORTED. NO ADDITIONAL INFORMATION IS AVAILABLE.

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; Insufficient Information; Osteolysis; Pain

  MAUDE report 20012238 ↗
• InjuryJan 30, 2024Naturally Worn; Insufficient Device Problem Information; Naturally Worn; Insufficient Device Problem Information

  AS REPORTED, THE PATIENT HAD AN INITIAL THA ON (B)(6) 2006. THE PATIENT IS PENDING REVISION; REASON UNKNOWN AND DATE UNKNOWN. NO FURTHER INFORMATION HAS BEEN PROVIDED.

  Patient problems: Failure of Implant; Insufficient Information

  MAUDE report 18611302 ↗
• InjuryJul 5, 2023Naturally Worn; Naturally Worn

  AS REPORTED, THE PATIENT HAD AN INITIAL THA ON (B)(6)2007. THE PATIENT HAD A PREVIOUS REVISION ON (B)(6)2014. THE PATIENT WAS REVISED AGAIN ON (B)(6)2023 DUE TO PAIN, WEAR AND SEVERE OSTEOLYSIS ON CT SCAN, PER THE SURGEON. NO ISSUES WITH SURGERY. REVISED TO A COMPETITORS CAGE AND DUAL MOBILITY. A NEW 22MM METAL HEAD WAS ALSO USED. NO OTHER PATIENT INFORMATION/MEDICAL HISTORY REPORTED.

  Patient problems: Failure of Implant; Implant Pain; Osteolysis

  MAUDE report 17262963 ↗
• InjuryJun 19, 2022Naturally Worn; Naturally Worn

  AS REPORTED, APPROXIMATELY TWELVE YEARS POST INITIAL LEFT THA, THE 66 Y/O MALE PATIENT HAD A REVISION DUE TO POLY WORN OVER TIME. PATIENT WAS REVISED WITH NEW ACUMATCH 36MM SIZE H 15 DEGREE LINER. HEAD ALSO REPLACED WITH BIOLOX DELTA 36MM +0. PT DEEMED STABLE. THERE WAS NO BREAKAGE OF DEVICE OR SURGICAL DELAY/PROLONGATION. PATIENT WAS LAST KNOWN TO BE IN STABLE CONDITION FOLLOWING THE EVENT. PHOTOS RECEIVED. THE DEVICE IS NOT AVAILABLE DUE TO HOSPITAL POLICY.

  Patient problems: Failure of Implant

  MAUDE report 14740092 ↗
• InjuryNov 1, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  AS REPORTED, APPROXIMATELY 11 YRS POSTOP THE INITIAL RTHA, THE (B)(6) Y/O MALE PATIENT PRESENTED COMPLAINING OF R HIP PAIN AND INSTABILITY. REVISED HEAD AND LINER. PATIENT WAS DEEMED STABLE. PATIENT WAS LAST KNOWN TO BE IN STABLE CONDITION FOLLOWING THE EVENT. THE DEVICE WILL NOT BE RETURNED FOR EVALUATION DUE TO HOSPITAL POLICY.

  Patient problems: Failure of Implant

  MAUDE report 12733825 ↗
• InjuryJul 1, 2020Naturally Worn; Naturally Worn

  AS REPORTED, APPROXIMATELY 14 YEARS POSTOP THE INITIAL LEFT THA THIS MALE PATIENT PRESENTED COMPLAINING OF PAIN. THE LEFT HIP ACETABULAR COMPONENTS WERE FOUND TO BE MALPOSITIONED AND WORN. A REVISION WAS COMPLETED. THE FEMORAL STEM WAS LEFT IMPLANTED, THE FEMORAL HEAD WAS REMOVED AND REPLACED. ALL COMPONENTS ON THE ACETABULAR SIDE WERE REPLACED WITH COMPETITOR DEVICES DUE TO MALPOSITIONING AND WEAR. THIS PATIENT HAD THE FEMORAL COMPONENTS IN THE LEFT HIP REVISED 1 YEAR AGO. THE FEMORAL SIDE WAS REMOVED AND REPLACED WITH COMPETITOR DEVICES, BUT ACETABULAR SIDE REMAINED IMPLANTED, JUST SWAPPED OUT THE POLY LINER. PATIENT WAS LAST KNOWN TO BE IN STABLE CONDITION FOLLOWING THE EVENT. DEVICES WILL NOT BE RETURNED DUE TO HOSPITAL POLICY.

  Patient problems: Failure of Implant

  MAUDE report 10220601 ↗
• InjuryOct 29, 2019Naturally Worn; Adverse Event Without Identified Device or Use Problem; Naturally Worn

  AS REPORTED, APPROXIMATELY 9 ½ YEARS POST THE INITIAL THA, A 70 Y/O MALE PATIENT WAS REVISED. THE SURGEON OPENED THE JOINT IN STANDARD FASHION AND DISLOCATED THE HIP. HE REMOVED OLD HEAD AND LINER. HE THEN IMPLANTED A NEW HEAD AND LINER IN THE SAME SIZES. REPORTEDLY, THIS WAS MORE OF A "TIRE CHANGE." THE SURGEON THEN RELOCATED THE HIP AND CLOSED THE WOUND. PATIENT WAS LAST KNOWN TO BE IN STABLE CONDITION FOLLOWING THE EVENT. DEVICES WERE DISPOSED OF BY THE HOSPITAL. BASED ON REVIEW OF ALL AVAILABLE INFORMATION, THERE IS NO EVIDENCE TO SUGGEST THAT THE REPORTED EVENT IS RELATED TO ANY DESIGN, MANUFACTURING, OR PATIENT RELATED ISSUES. THE CAUSE OF THE REVISION CANNOT BE CONCLUSIVELY DETERMINED SINCE THE DEVICES WERE NOT RETURNED. THE MOST LIKELY CAUSE IS EXPECTED WEAR.

  Patient problems: Failure of Implant; No Code Available

  MAUDE report 9250160 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K051556. One submission often covers many models, so check the product and lot details in each record.

• Z-2133-2021 · Jun 29, 2021 · Open, Classified
  Exactech Connexion GXL acetabular polyethylene liners used in the following systems: Catalog numbers 132-32-XX, Acumatch GXL 15 Degree Liner, 32mm; Novation GXL Liner, Lipped Ant,
• Z-2124-2021 · Jun 29, 2021 · Open, Classified
  Exactech Connexion GXL acetabular polyethylene liners used in the following systems: Catalog numbers 134-28-XX, Acumatch GXL, Ext Cov Liner, 28mm. Orthopedic hip implant component
• Z-2114-2021 · Jun 29, 2021 · Open, Classified
  Exactech Connexion GXL acetabular polyethylene liners used in the following systems: Catalog numbers 104-36-XX, MCS +5GXL Liner 5/15 DEG and MCS GXL Liner 5/15 DEG. Orthopedic hip
• Z-2131-2021 · Jun 29, 2021 · Open, Classified
  Exactech Connexion GXL acetabular polyethylene liners used in the following systems: Catalog numbers 138-28-XX, Acumatch GXL 15 Degree, +5 Lat Liner, 28mm; Novation GXL 10 Deg Line
• Z-2117-2021 · Jun 29, 2021 · Open, Classified
  Exactech Connexion GXL acetabular polyethylene liners used in the following systems: Catalog numbers 130-32-XX, Acumatch GXL 0 Degree Liner, 32mm; and Novation GXL Liner, Neutral,
• Z-2113-2021 · Jun 29, 2021 · Open, Classified
  Exactech Connexion GXL acetabular polyethylene liners used in the following systems: Catalog numbers 104-32-XX, MCS +5GXL Liner 5/15 DEG and MCS GXL Liner 5/15 DEG. Orthopedic hip
• Z-2118-2021 · Jun 29, 2021 · Open, Classified
  Exactech Connexion GXL acetabular polyethylene liners used in the following systems: Catalog numbers 130-36-XX, Acumatch GXL 0 Degree Liner, 36mm; and Novation GXL Liner, Neutral,
• Z-2116-2021 · Jun 29, 2021 · Open, Classified
  Exactech Connexion GXL acetabular polyethylene liners used in the following systems: Catalog numbers 130-28-XX, Acumatch GXL 0 Degree Liner, 28mm; Novation GXL Liner, Neutral, 28m
• Z-2112-2021 · Jun 29, 2021 · Open, Classified
  Exactech Connexion GXL acetabular polyethylene liners used in the following systems: Catalog numbers 104-28-XX, MCS +5GXL Liner 5/15 DEG and MCS GXL Liner 5/15 DEG. Orthopedic hip
• Z-2121-2021 · Jun 29, 2021 · Open, Classified
  Exactech Connexion GXL acetabular polyethylene liners used in the following systems: Catalog numbers 132-28-XX, Acumatch GXL 15 Degree Liner, 28mm; Novation GXL Liner, G0, 28mm ID;