MCS 104-32-45Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 10885862013606), received between Nov 8, 2023 and Apr 17, 2024 — classified as 3 injuries.

The most frequently reported specific device problem is “Naturally Worn” (3 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 16, 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 · Recall details · 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-2113-2021 · Root cause: Unknown/Undetermined by firm · Recall details · 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.

• InjuryApr 17, 2024Naturally Worn; Naturally Worn

  IT WAS REPORTED VIA LEGAL DOCUMENTATION THAT A PATIENT HAD A RIGHT HIP ARTHROPLASTY FIRST REVISION ON (B)(6) 2018, AND THEN EXPERIENCED SECOND REVISION SURGICAL PROCEDURE ON (B)(6) 2023 APPROXIMATELY 10 YEARS AND 2 MONTHS AFTER FIRST REVISION. OP REPORT DATED (B)(6) 2023 - POSTOPERATIVE DIAGNOSIS; FAILED RIGHT THA DUE TO ASYMMETRIC POLYWEAR AND OSTEOLYSIS AND PSEUDOTUMOR (ANTERIOR AND TROCHANTERIC). NO IMAGES WERE PROVIDED. THERE IS NO OTHER INFORMATION AVAILABLE.

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

  MAUDE report 19123994 ↗
• InjuryFeb 6, 2024Fracture; Naturally Worn; Fracture; Naturally Worn

  IT WAS REPORTED THAT A 76 YO MALE PATIENT, INITIAL RIGHT HIP IMPLANTED ON NOVEMBER 10, 2020, UNDERWENT A REVISION PROCEDURE ON (B)(6) 2024, APPROXIMATELY 3 YEARS 2 MONTHS POST THE INITIAL PROCEDURE. THE PATIENT PRESENTED WITH PAIN. RADIOGRAPHS SHOWED WEAR. THE SURGEON DECIDED TO REVISE. NO REPLACEMENT LINERS WERE AVAILABLE, SO THE SURGEON CEMENTED A COMPETITOR¿S LINER IN THE EXISTING MCS CUP. HE PUT A REPLACEMENT EXACTECH 11/13 BALL ON THE EXISTING STEM. THE LINER WAS CRACKED UPON SURGICAL DISSECTION. ALL PARTS AND PIECES WERE REMOVED. IT APPEARED THAT THE LINER WAS NOT SEATED PROPERLY AS THE DOME LOCKING TAB WAS SHEARED OFF. NO SURGICAL DELAYS WERE REPORTED. X-RAYS WERE PROVIDED. THE PATIENT WAS LAST KNOWN TO BE IN STABLE CONDITION FOLLOWING THE EVENT. NO DEVICE RETURNS FOR ANALYSIS ANTICIPATED. THE DEVICES WERE SENT TO PATHOLOGY AT THE HOSPITAL PER THEIR PROTOCOL. DEVICE IMAGES WERE PROVIDED. NO FURTHER INFORMATION.

  Patient problems: Pain

  MAUDE report 18654890 ↗
• InjuryNov 8, 2023Fracture; Naturally Worn; Fracture; Naturally Worn

  IT WAS REPORTED VIA LEGAL DOCUMENTATION THAT ON (B)(6) 2019 THE PATIENT WAS REVISED TO EXACTECH DEVICES AND THEN APPROXIMATELY 13 MONTHS LATER WAS REVISED A SECOND TIME ON (B)(6) 2020. PATIENT REVISED TO COMPETITOR DEVICES. ON (B)(6) 2020, AS PATIENT WAS PUTTING ON HIS SHOES, HE FELT A "SNAP" IN HIS RIGHT GROIN, FOLLOWED BY SIGNIFICANT PAIN. ON (B)(6) 2020, HE EXPERIENCED THREE MORE "SNAPS" AND MORE PAIN AT HIS RIGHT GROIN. ON (B)(6) 2020, PATIENT PRESENTED TO DOCTOR WITH COMPLAINTS OF RIGHT HIP PAIN. AFTER A PHYSICAL EXAMINATION, DOCTOR RECOMMENDED HE WALK WITH A CANE IN HIS LEFT HAND "FULL TIME," AND HE SCHEDULED HIM FOR A FOLLOW UP VISIT. ON (B)(6) 2020, PATIENT RETURNED TO DOCTOR WITH COMPLAINTS OF CONTINUING RIGHT HIP PAIN AND DIFFICULTY WALKING. IN HIS MEDICAL RECORDS FOR THAT DATE UNDER "IMPRESSION" DOCTOR DOCUMENTED THE FOLLOWING: THE X-RAY SHOWS SUBSTANTIAL POLYETHYLENE WEAR. THIS HIP IS EITHER SUBLUXATING OR HE HAS A FRACTURED HIP LINER. PLAN TO REVISE THE ENTIRE ACETABULAR COMPONENT. THE FEMORAL HEAD WILL BE REVIEWED. DOCTOR STATED THAT THEY WOULD ENCOUNTER HETEROTOPIC BONE. THE PLAN WAS TO USE PERIOPERATIVE ASPIRIN TO HELP PREVENT NEW BONE FORMATION. FURTHER, UNDER "TRE

  Patient problems: Failure of Implant; Pain

  MAUDE report 18091213 ↗

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-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-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-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-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-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-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;