MCSRecalls & reported problems across all models

We found 25 models of MCS by Exactech, Inc. in the FDA's device registry (GUDID). Together they are named in 7 adverse event reports in the FDA's MAUDE database, received between Sep 29, 2022 and Jul 17, 2024 — classified as 7 injuries.

The most frequently reported specific device problem is “Naturally Worn” (6 reports).

5 FDA recall records name at least one of these models by its device identifier, 5 still open.

Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event. Widely used products collect more reports, so totals can't be used to compare products or estimate failure rates. Only reports that name a model's exact device identifier are counted. What reports can and can't tell you · How this data works

MCS recalls

FDA recall records that name at least one of these models by its device identifier, newest first. Each recall usually covers specific models or lots, so check the details.

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 · names 7 of these models · Recall details · FDA record ↗

2. 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-1725-2022 · Root cause: Process control · names 3 of these models · Recall details · FDA record ↗

3. 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-2114-2021 · Root cause: Unknown/Undetermined by firm · names 5 of these models · Recall details · FDA record ↗

4. 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 · names 8 of these models · Recall details · FDA record ↗

5. 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 · names 9 of these models · Recall details · FDA record ↗

Most reported MCS problems

MCS models

25 models, most reported first. Each model has its own page with its reports, recalls and device details.

• MCS 104-28-44

  Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Cemented
  2 recalls3 reports
• MCS 104-32-45

  Prosthesis, Hip, Semi-Constrained, Uncemented, Metal/Polymer, Non-Porous, Calicum-Phosphate
  2 recalls3 reports
• MCS 104-32-46

  Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Cemented
  2 recalls1 report
• MCS 104-28-43

  Prosthesis, Hip, Semi-Constrained, Uncemented, Metal/Polymer, Non-Porous, Calicum-Phosphate
  2 recalls0 reports
• MCS 104-28-45

  Prosthesis, Hip, Semi-Constrained, Uncemented, Metal/Polymer, Non-Porous, Calicum-Phosphate
  2 recalls0 reports
• MCS 104-36-46

  Prosthesis, Hip, Semi-Constrained, Uncemented, Metal/Polymer, Non-Porous, Calicum-Phosphate
  2 recalls0 reports
• MCS 104-36-47

  Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Cemented
  2 recalls0 reports
• MCS 104-28-46

  Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Cemented
  1 recall0 reports
• MCS 104-28-47

  Prosthesis, Hip, Semi-Constrained, Uncemented, Metal/Polymer, Non-Porous, Calicum-Phosphate
  1 recall0 reports
• MCS 104-28-53

  Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Cemented
  1 recall0 reports
• MCS 104-28-55

  Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Cemented
  1 recall0 reports
• MCS 104-28-56

  Prosthesis, Hip, Semi-Constrained, Uncemented, Metal/Polymer, Non-Porous, Calicum-Phosphate
  1 recall0 reports
• MCS 104-28-57

  Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Cemented
  1 recall0 reports
• MCS 104-32-47

  Prosthesis, Hip, Semi-Constrained, Uncemented, Metal/Polymer, Non-Porous, Calicum-Phosphate
  1 recall0 reports
• MCS 104-32-53

  Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Cemented
  1 recall0 reports
• MCS 104-32-54

  Prosthesis, Hip, Semi-Constrained, Uncemented, Metal/Polymer, Non-Porous, Calicum-Phosphate
  1 recall0 reports
• MCS 104-32-55

  Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Cemented
  1 recall0 reports
• MCS 104-32-56

  Prosthesis, Hip, Semi-Constrained, Uncemented, Metal/Polymer, Non-Porous, Calicum-Phosphate
  1 recall0 reports
• MCS 104-32-57

  Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Cemented
  1 recall0 reports
• MCS 104-36-55

  Prosthesis, Hip, Semi-Constrained, Uncemented, Metal/Polymer, Non-Porous, Calicum-Phosphate
  1 recall0 reports
• MCS 104-36-56

  Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Cemented
  1 recall0 reports
• MCS 104-36-57

  Prosthesis, Hip, Semi-Constrained, Uncemented, Metal/Polymer, Non-Porous, Calicum-Phosphate
  1 recall0 reports
• MCS 146-28-04

  Prosthesis, Hip, Constrained, Cemented Or Uncemented, Metal/Polymer
  1 recall0 reports
• MCS 146-28-05

  Prosthesis, Hip, Constrained, Cemented Or Uncemented, Metal/Polymer
  1 recall0 reports
• MCS 146-32-06

  Prosthesis, Hip, Constrained, Cemented Or Uncemented, Metal/Polymer
  1 recall0 reports

Recent MCS adverse event reports

The 7 most recent reports across all models, in the reporter's own words as published by the FDA.

• InjuryJul 17, 2024Naturally Worn; Insufficient Device Problem Information; Naturally Worn; Insufficient Device Problem Information

  IT WAS REPORTED VIA LEGAL DOCUMENTATION THAT APPROXIMATELY 95 MONTHS AFTER A TOTAL HIP REPLACEMENT PROCEDURE, THE PATIENT MAY REQUIRE A REVISION. NO FURTHER ISSUES OR COMPLICATIONS WERE REPORTED. NO ADDITIONAL INFORMATION IS AVAILABLE.

  Patient problems: Insufficient Information

  MAUDE report 19767002 ↗
• 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 ↗
• 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 ↗

Other Exactech, Inc. products

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