Acumatch A Series 132-28-25Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 10885862023070), received between Aug 17, 2020 and Jan 28, 2025 — classified as 4 injuries.

The most frequently reported specific device problem is “Naturally Worn” (4 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-2121-2021 · Root cause: Unknown/Undetermined by firm · Recall details · FDA record ↗

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.

• InjuryJan 28, 2025Naturally Worn; Naturally Worn

  IT WAS REPORTED VIA LEGAL DOCUMENTATION THAT A PATIENT HAD A LEFT TOTAL HIP ARTHROPLASTY FOR ARTHRITIS ON (B)(6) 2009 AND THEN EXPERIENCED A REVISION SURGICAL PROCEDURE ON(B)(6) 2016 APPROXIMATELY 7 YEARS AND 4 MONTHS AFTER INITIAL IMPLANT. PATIENT HAS EXPERIENCED THE FOLLOWING INJURIES INCLUDING SIGNIFICANT PAIN, AND DISCOMFORT, GAIT IMPAIRMENT, POOR BALANCE, DIFFICULTY WALKING, COMPONENT PART LOOSENING, PROTHESIS WEAR, SOFT TISSUE DAMAGE, AND BONE LOSS. PATIENT WAS REVISED TO COMPETITOR'S DEVICES/ POSTOPERATIVE DIAGNOSIS: LEFT HIP FAILED HIP. PATIENT PRESENTED TO THE SURGEON WITH PAIN AND RADIOGRAPHIC AND CLINICAL EVIDENCE OF ACETABULAR COMPONENT FAILURE. THE FEMUR WAS IDENTIFIED AND EXAMINED AND REVEALED A WELL-FIXED FEMORAL COMPONENT. THE ACETABULUM WAS INSPECTED AND DID APPEAR TO HAVE SIGNIFICANT ACETABULAR BONE LOSS TO THE PUBIS, ISCHIUM AND SUPERIOR DOME WITH GROSS DISTORTION OF THE HEMISPHERE. FINDINGS: LEFT HIP WITH SEVERE ACETABULAR BONE LOSS PAPROSKY GRADE 2, GROSSLY LOOSE ACETABULAR COMPONENT. THERE WERE NO INTRAOPERATIVE COMPLICATIONS, THE PATIENT WAS TAKEN TO RECOVERY ROOM IN STABLE CONDITION. THE PATIENT PASSED AWAY ON (B)(6) 2022, THOUGH IT IS NOT INDICATED OR SUGGE

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

  MAUDE report 21257544 ↗
• InjuryApr 1, 2024Naturally Worn; Naturally Worn

  IT WAS REPORTED VIA LEGAL DOCUMENTATION THAT A PATIENT HAD A RIGHT TOTAL HIP ARTHROPLASTY ON (B)(6) 2007 AND THEN EXPERIENCED A REVISION SURGICAL PROCEDURE ON (B)(6) 2020 APPROXIMATELY 12 YEARS AND 7 MONTHS AFTER INITIAL IMPLANT. NO OTHER PATIENT INFORMATION / MEDICAL HISTORY REPORTED. NO IMAGES OF THE DEVICES ARE PROVIDED. THE DEVICE WILL NOT BE RETURNED. THERE IS NO OTHER INFORMATION AVAILABLE.

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; Failure of Implant

  MAUDE report 19011102 ↗
• InjuryJul 17, 2023Naturally Worn; Adverse Event Without Identified Device or Use Problem; Naturally Worn; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A 67 YO FEMALE PATIENT, INITIAL RIGHT HIP IMPLANTED ON MARCH 7, 2011, UNDERWENT A REVISION PROCEDURE ON (B)(6) 2023 , APPROXIMATELY 12 YEARS 3 MONTHS POST THE INITIAL PROCEDURE. THE PATIENT WAS SEEN BY THE SURGEON DUE TO SLIGHT HIP PAIN. THE SURGEON SCHEDULED SURGERY TO SWITCH OUT THE LINER AND HEAD AND TO CHECK THE STABILITY OF THE STEM AND CUP. DURING SURGERY, THE SURGEON REMOVED THE HEAD AND THEN PROCEEDED TO REMOVE THE LINER. HE CHECKED THE STABILITY OF THE CUP WHICH SEEMED WELL FIXED. HE DECIDED TO REPLACE THE LINER WITH A NEW ACCUMATCH SZ E LINER 15 DEGREE VIT E LINER. THE SURGEON INSPECTED THE STEM. THE STEM SEEMED TO BE WELL FIXED, AND THE NECK AND TRUNNION SEEMED TO BE IN GOOD SHAPE. HE THEN IMPLANTED A 28 +10 COBALT CHROME HEAD AND REDUCED THE HIP. THE LEG LENGTH LOOKED GOOD, AND THE PATIENT WAS STABLE. THERE WERE NO SURGICAL DELAYS OR DEVICE BREAKAGES DURING THE PROCEDURE. THE PATIENT WAS LAST KNOWN TO BE IN STABLE CONDITION FOLLOWING THE EVENT. NO DEVICE RETURNS ANTICIPATED. THE HOSPITAL IS KEEPING THE DEVICES. NO FURTHER INFORMATION.

  Patient problems: Pain

  MAUDE report 17333632 ↗
• InjuryAug 17, 2020Naturally Worn; Naturally Worn

  AS REPORTED, APPROXIMATELY 6 YEARS POSTOP THE INITIAL THA, THIS MALE PATIENT EXPERIENCED A REVISION DUE TO POLY WEAR. DEVICE TO BE RETURNED.

  Patient problems: Failure of Implant

  MAUDE report 10417725 ↗

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-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-2122-2021 · Jun 29, 2021 · Open, Classified
  Exactech Connexion GXL acetabular polyethylene liners used in the following systems: Catalog numbers 132-36-XX, Acumatch GXL 15 Degree Liner, 36mm, and Novation GXL Liner, Lipped A
• 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-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-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-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-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-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-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