MCS 104-28-44Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 10885862013507), received between Sep 29, 2022 and Oct 2, 2023 — classified as 3 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.

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. How this data works · Data updated Oct 13, 2026.

Recalls naming this device

1. Aug 11, 2022Open, 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 · FDA record ↗

2. Jun 29, 2021Open, 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-2112-2021 · Root cause: Unknown/Undetermined by firm · FDA record ↗

Most reported problems

Recent adverse event reports

The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• InjuryOct 2, 2023Naturally Worn; Naturally Worn

  IT WAS REPORTED VIA LEGAL DOCUMENTATION THAT A PATIENT HAD A REVISION OF RIGHT HIP ARTHROPLASTY FROM ANOTHER DEVICE FOR: STATUS POST RIGHT THA PERFORMED APPROX. 14 YEARS AGO, IT WAS FOUND THAT THERE WAS A CYST OF THE SUPERIOR ASPECT OF THE ACETABULUM. HOWEVER, THE ACETABULAR COMPONENT WAS FOUND TO BE RIGID IN ITS FIXATION. OSTEOLYTIC LESION ON SUPERIOR ASPECT OF ACETABULUM. THE PATIENT WAS REVISED TO AN EXACTECH HIP DEVICE ON (B)(6) 2008 AND THEN APPROXIMATELY 7 YEARS, 9 MONTHS LATER EXPERIENCED A SECOND REVISION. ON (B)(6) 2016 THE PATIENT WAS REVISED TO AN EXACTECH COCR FEMORAL HEAD 36MM, AND THE POLY LINER AND ACETABULAR COMPONENT OF A COMPETITOR. REVISION OPERATIVE REPORT OF (B)(6) 2016- POSTOPERATIVE DIAGNOSIS-FAILED THA WITH MASSIVE OSTEOLYSIS BOTH RETROACETABULAR AND PROXIMAL FEMORAL. SIGNIFICANT AMOUNT OF OSTEOLYSIS AROUND ACETABULUM. HAD POLYETHYLENE WEAR AND UNDERWENT A HEAD LINER EXCHANGE IN 2008. HAD EARLY WEAR OF THIS POLYETHYLENE LINER SUCH THAT IT CREATED SIGNIFICANT OSTEOLYSIS BEHIND HIS ACETABULUM AND IN HIS PROXIMAL FEMUR. PROCEDURE: THERE WERE SIGNS OF SIGNIFICANT POLYETHYLENE DEBRIS. DEBRIDEMENT OF PROXIMAL FEMORAL OSTEOLYSIS. SIGNIFICANT AMOUNT OF OSTEOLYSIS AR

  Patient problems: Osteolysis

  MAUDE report 17855684 ↗
• InjuryApr 20, 2023Naturally Worn; Naturally Worn

  PER A REPORT FROM THE LEGAL DEPARTMENT, THE PATIENT HAD AN INITIAL RIGHT HIP REPLACEMENT ON (B)(6) 2008. APPROXIMATELY 6 YEARS AND 10 MONTHS AFTER THE INITIAL PROCEDURE THE PATIENT HAD A HIP REVISION ON (B)(6) 2015 DUE TO SUFFERING FROM SYMPTOMS ASSOCIATED WITH EXCESSIVE WEAR OF THE GXL, INCLUDING, BUT NOT LIMITED TO INSTABILITY, PAIN AND LACK OF MOBILITY. THERE IS NO OTHER PATIENT DEMOGRAPHIC OR MEDICAL HISTORY AVAILABLE. THERE IS NO INFORMATION ON THE SURGICAL PROCEDURE OR PATIENT OUTCOME. THERE IS NO DEVICE RETURN. THERE ARE NO PHOTOS OR OTHER IMAGES OF THE DEVICE PROVIDED. NO ADDITIONAL INFORMATION IS AVAILABLE.

  Patient problems: Insufficient Information

  MAUDE report 16775699 ↗
• InjurySep 29, 2022Detachment of Device or Device Component; Device-Device Incompatibility; Detachment of Device or Device Component; Device-Device Incompatibility

  AS REPORTED, APPROXIMATELY 5.5 YEARS POST OP THE INITIAL THA, THIS FEMALE PATIENT WAS REVISED. PATIENT WAS HAVING ISSUES SO THE SURGEON SWAPPED OUT THE HEAD AND LINER FOR A NEW ONES. THE LINER WAS MOVING WITHIN THE CUP. DEVICES WILL NOT BE RETURNING, HOSPITAL KEPT.

  Patient problems: Failure of Implant; Insufficient Information

  MAUDE report 15503212 ↗

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-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-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-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-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-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-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-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-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