Acumatch A Series 132-32-27Recalls & reported problems

Summary

The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 10885862023247), received between Apr 25, 2023 and May 30, 2024 — classified as 6 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-2133-2021 · Root cause: Unknown/Undetermined by firm · Recall details · FDA record ↗

Most reported problems

Recent adverse event reports

The 6 most recent of 6 reports, in the reporter's own words as published by the FDA.

• InjuryMay 30, 2024Naturally Worn; Naturally Worn

  IT WAS REPORTED THAT THIS FEMALE PATIENT HAD A HIP REVISION APPROXIMATELY 16 YEARS POST OP. REASON FOR THE REVISION WAS NOT REPORTED.

  Patient problems: Failure of Implant; Insufficient Information

  MAUDE report 19424434 ↗
• InjuryMar 19, 2024Naturally Worn; Naturally Worn

  IT WAS REPORTED VIA LEGAL DOCUMENTATION THAT A PATIENT HAD A RIGHT HIP IMPLANT ON (B)(6) 2008, AND THEN EXPERIENCED A REVISION SURGICAL PROCEDURE ON (B)(6) 2023, APPROXIMATELY 14 YEARS, 5 MONTHS AFTER INITIAL IMPLANT. THERE WAS NO OTHER PATIENT/MEDICAL INFORMATION PROVIDED. NO X-RAYS OR IMAGES WERE PROVIDED. THE DEVICE WILL NOT BE RETURNED. THERE IS NO OTHER INFORMATION AVAILABLE.

  Patient problems: Failure of Implant; Pain

  MAUDE report 18935071 ↗
• InjuryDec 19, 2023Naturally Worn; Adverse Event Without Identified Device or Use Problem; Naturally Worn; Adverse Event Without Identified Device or Use Problem

  AS REPORTED, APPROXIMATELY 17 YEARS POST OP INITIAL RIGHT THA, THIS FEMALE PATIENT WAS REVISED DUE TO PAIN. CUP WAS REMOVED. COMPETITORS ACETABULAR COMPONENT IMPLANTED. NO ISSUES WITH SURGERY. EXPLANTS NOT AVAILABLE. PRODUCT NOT RETURNING - EXPLANTS NOT AVAILABLE. NO OTHER INFORMATION PROVIDED.

  Patient problems: Failure of Implant; Pain

  MAUDE report 18360154 ↗
• InjuryNov 6, 2023Naturally Worn; Naturally Worn

  AS REPORTED, THE PATIENT HAD AN INITIAL LEFT THA ON (B)(6) 2009. THE PATIENT WAS REVISED ON 10-OCT-2023 DUE TO THE POLY WEARING DOWN OVER TIME. THERE WAS NO REPORTED BREAKAGE OF A DEVICE OR SURGICAL DELAY/PROLONGATION. THE PATIENT WAS LAST KNOWN TO BE IN STABLE CONDITION FOLLOWING THE EVENT.

  Patient problems: Failure of Implant; Insufficient Information

  MAUDE report 18081013 ↗
• InjuryMay 25, 2023Unstable; Naturally Worn; Adverse Event Without Identified Device or Use Problem; Unstable; Naturally Worn; Adverse Event Without Identified Device or Use Problem

  AS REPORTED, APPROXIMATELY 14.6 YEARS POST INITIAL RIGHT THA, THE MALE PATIENT WAS BROUGHT IN FOR A REVISION SURGERY. THE SURGEON CHANGES THE LINER AND HEAD. THE HEAD WAS INCREASED BY 3.5MM. PATIENT WAS REVISED TO EXACTECH DEVICES. THE HIP PERFORMED WELL AND THE SURGEON WAS HAPPY WITH THE OUTCOME. THERE WAS NO BREAKAGE OF THE DEVICE OR SURGICAL DELAY/PROLONGATION. SALES REP WAS UNABLE TO OBTAIN IMAGES OR X-RAYS. THE DEVICES ARE NOT AVAILABLE FOR EVALUATION AS THEY WERE THROWN OUT.

  Patient problems: Failure of Implant; Joint Laxity; Pain

  MAUDE report 17003073 ↗
• InjuryApr 25, 2023Unstable; Naturally Worn; Unstable; Naturally Worn

  IT WAS REPORTED THAT A FEMALE PATIENT, INITIAL LEFT HIP IMPLANTED WITH A GXL LINER ON (B)(6) 2008, UNDERWENT A REVISION PROCEDURE ON (B)(6) 2023, APPROXIMATELY 15 YEARS 1 MONTH POST THE INITIAL PROCEDURE. THE REPORTED INFORMATION INDICATED THAT SEVERELY WORN POLY LEAD TO SOME INSTABILITY AND OSTEOLYSIS. IT OCCURRED OVER TIME. THE COCR HEAD AND LINER WERE EXCHANGED. THE PATIENT WAS REVISED TO EXACTECH DEVICES. THE EVENT WAS NOT RELATED TO A BREAKAGE OF DEVICE. THERE WERE NO SURGICAL DELAYS. THE PATIENT WAS LAST KNOWN TO BE IN STABLE CONDITION FOLLOWING THE EVENT. NO DEVICE RETURNS ANTICIPATED DUE TO HOSPITAL POLICIES. NO X-RAYS OR DEVICE IMAGES WERE ABLE TO BE OBTAINED. NO FURTHER INFORMATION.

  Patient problems: Joint Laxity; Osteolysis

  MAUDE report 16806525 ↗

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-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-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-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-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-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-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-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;
• 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