Acumatch A Series 138-36-28Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 10885862024824), received between Aug 18, 2020 and May 4, 2026 — classified as 4 injuries.

The most frequently reported specific device problem is “Naturally Worn” (2 reports).

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

11 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-2132-2021 · 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.

• InjuryMay 4, 2026Naturally Worn

  IT WAS REPORTED THAT THE PATIENT PREVIOUSLY UNDERWENT A LEFT TOTAL HIP ARTHROPLASTY. OVER TIME, THE POLYETHYLENE COMPONENT EXHIBITED WEAR, AND THE PATIENT EXPERIENCED ASSOCIATED PAIN. A REVISION PROCEDURE WAS PERFORMED. THE FEMORAL STEM WAS ASSESSED INTRAOPERATIVELY AND FOUND TO BE STABLE AND WELL-FIXED; THEREFORE, IT WAS RETAINED. THE PATIENT WAS REVISED TO AN EXACTECH BIOLOX OPTION FEMORAL HEAD AND ADAPTER. THE ACETABULAR LINER WAS EXCHANGED TO A COMPETITOR¿S DEVICE. THE PATIENT WAS LAST KNOWN TO BE IN STABLE CONDITION FOLLOWING THE EVENT. NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: Pain

  MAUDE report 25071705 ↗
• InjuryAug 15, 2024Detachment of Device or Device Component; Naturally Worn; Detachment of Device or Device Component; Naturally Worn

  THE PATIENT HAS FILED A SHORT-FORM COMPLAINT IN A MULTIDISTRICT LITIGATION TITLED IN RE: EXACTECH POLYETHYLENE ORTHOPEDIC PRODUCTS LIABILITY LITIGATION, MDL NO. 3044, AND PENDING IN THE EASTERN DISTRICT OF NEW YORK. PER THE TRANSFER ORDER CREATING THIS MULTIDISTRICT LITIGATION, ¿PLAINTIFFS¿ALLEGE THAT THEIR KNEE OR HIP REPLACEMENT DEVICES.. FAILED PREMATURELY BECAUSE OF DEGRADATION OF THE DEVICE¿S POLYETHYLENE COMPONENT, WHICH RESULTED IN THE PREMATURE REMOVAL (OR PLANNED REMOVAL) OF THE PROSTHESIS AT ISSUE.¿ BECAUSE THE PATIENT HAS FILED A SUIT IN THIS MULTIDISTRICT LITIGATION, THE PATIENT APPEARS TO ALLEGE THAT THE PATIENT WAS INJURED AS A RESULT OF PREMATURE WEAR OF AN EXACTECH POLYETHYLENE DEVICE.

  Patient problems: Joint Dislocation; Joint Laxity; Metal Related Pathology; Osteolysis; Scar Tissue; Synovitis

  MAUDE report 19992766 ↗
• InjuryAug 15, 2023Unstable; Device Dislodged or Dislocated; Adverse Event Without Identified Device or Use Problem; Unstable; Device Dislodged or Dislocated; Adverse Event Without Identified Device or Use Problem

  AS REPORTED, APPROXIMATELY 6 YEARS POST OP INITIAL RIGHT TKA, THIS 78 Y/O MALE PATIENT WAS REVISED. HIP INSTABILITY CAUSED DISLOCATION. CONSTRAINED CUP WAS NEEDED, TO ACCOMMODATE, AN EXACTECH HEAD WAS MATCHED WITH COMPETITORS CUP. ACETABULAR SIDE WAS FULLY REVISED TO DIFFERENT MANUFACTURER. PATIENT WAS LAST KNOWN TO BE IN STABLE CONDITION FOLLOWING THE EVENT. NO OTHER MEDICAL/PATIENT INFORMATION PROVIDED. UNABLE TO OBTAIN IMAGES OR X-RAYS. PRODUCT NOT RETURNING DUE TO HOSPITAL POLICY.

  Patient problems: Failure of Implant; Joint Dislocation; Joint Laxity

  MAUDE report 17549580 ↗
• InjuryAug 18, 2020Biocompatibility; Biocompatibility

  AS REPORTED, APPROXIMATELY 13 YEARS POSTOP THE INITIAL THA THIS (B)(6) FEMALE PATIENT WAS REVISE DUE TO DEVELOPING AN INFECTION NOT RELATED TO IMPLANTS. PATIENT THEN STARTED TO COMPLAIN OF HIP PAIN. A REVISION WAS PERFORMED (B)(6) 2020. STEM, LINER AND HEAD REMOVED. PATIENT WAS LAST KNOWN TO BE IN STABLE CONDITION FOLLOWING THE EVENT. DEVICES NOT RETURNING DUE TO HOSPITAL POLICY.

  Patient problems: Hypersensitivity/Allergic reaction

  MAUDE report 10419762 ↗

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-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-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-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-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-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;
• 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-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-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-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