Acumatch A Series 138-28-27Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 10885862024602), received between Oct 14, 2019 and Dec 20, 2019 — classified as 2 injuries.

The most frequently reported specific device problem is “Device Dislodged or Dislocated” (1 report).

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-2131-2021 · Root cause: Unknown/Undetermined by firm · Recall details · FDA record ↗

Most reported problems

Recent adverse event reports

The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• InjuryDec 20, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  AS REPORTED, THIS 76 Y/O MALE WAS INITIALLY IMPLANTED ON (B)(6)05. THERE WAS A REVISION ON (B)(6) 2017 THE REASON WAS NOT REPORTED, THAT WAS SUBMITTED IN REPORT #1038671-2019-00509 (CASE# 00001501). ON (B)(6) 2019 AND REVISION OCCURRED DUE TO DISLOCATION AND WAS REPORTED IN REPORT #1038671-2019-00499 (CASE# 00001499). IN THIS REVISION ON (B)(6) 2019 (CASE# 00001893), THE SURGEON DECIDED TO REMOVE THE ACETABULAR CUP, REAMED UP A FEW SIZES, IMPLANTED A COMPETITOR¿S REVISION CUP AND IMPLANTED A LINER INTO THE CUP. THE SURGEON TRIALED FEMORAL HEADS AND USED ONE THAT MADE THE HIP VERY STABLE AND THEN IMPLANTED THE FEMORAL HEAD AND THEN CLOSED THE JOINT IN STANDARD FASHION. THE PATIENT LEFT THE OR IN STABLE CONDITION. DEVICES WILL NOT BE RETURNED PER HOSPITAL POLICY. THE REASON FOR THE REVISION WAS NOT REPORTED.

  Patient problems: No Information

  MAUDE report 9504006 ↗
• InjuryOct 14, 2019Device Dislodged or Dislocated; Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ON (B)(6) 2019 THIS PATIENT HAD A SECOND REVISION SURGERY. THIS REVISION WAS DUE TO THE PATIENT WOKE UP IN HIS BED AND HIS HIP WAS DISLOCATED. THE SURGEON DECIDED TO REMOVE THE LINER AND HEAD AND PUT THE SAME LINER BACK IN WITH A +10 HEAD IN TO GIVE THE PATIENT MORE LEG LENGTH. THIS MADE THE PATIENT STABLE. THE PATIENT LEFT THE OR IN STABLE CONDITION AND IS EXPECTED TO HAVE A GOOD OUTCOME. HOSPITAL DID NOT RELEASE IMPLANTS TO BE RETURNED TO EXACTECH. UPON REVIEW OF THE AVAILABLE INFORMATION, THERE IS NO EVIDENCE THAT THIS IS A DEVICE RELATED MALFUNCTION AND THERE IS NO ALLEGATION AGAINST THE DEVICE. IMPLANTATION OF A TOTAL JOINT COULD RESULT PAIN, INFECTION, OR LOOSENING OF TOTAL JOINT HARDWARE. THE MOST LIKELY CAUSE OF THE REPORTED EVENT IS PATIENT CONDITIONS. ORIGINAL LEFT TOTAL HIP ARTHROPLASTY, MALE PATIENT, (B)(6) 2005. THIS PATIENT HAD A REVISION SURGERY (B)(6) 2017 DUE TO REASON NOT REPORTED. REVISED A (CN: (B)(4), SN: (B)(6)) 28MM +5 FEMORAL HEAD AND (CN: (B)(4), SN: (B)(6)) 28MM SIZE G LINER. A SEARCH OF THE COMPLAINT HAS FOUND THAT THIS REVISION WAS NOT REPORTED TO EXACTECH. THEREFORE THE CASE WILL BE CAPTURED IN CASE (B)(4).

  Patient problems: Joint Dislocation

  MAUDE report 9184456 ↗

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-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-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-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-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-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-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-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