Mpact Acetabular System 01.32.158DHRecalls & reported problems

Summary

The FDA's MAUDE database contains 18 adverse event reports that list this exact device (DI 07630030810893), received between Sep 20, 2017 and Dec 19, 2025 — classified as 18 injuries.

The most frequently reported specific device problem is “Malposition of Device” (4 reports).

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.

Most reported problems

Recent adverse event reports

The 18 most recent of 18 reports, in the reporter's own words as published by the FDA.

• InjuryDec 19, 2025Device Appears to Trigger Rejection; Device Appears to Trigger Rejection

  REVISION SURGERY AT ABOUT 9 MONTHS AFTER THE PRIMARY DUE TO INFECTION. ALL COMPONENTS REVISED SUCCESSFULLY.

  Patient problems: Medical device site infection

  MAUDE report 23850112 ↗
• InjuryNov 21, 2024Device Appears to Trigger Rejection; Device Appears to Trigger Rejection

  THE PATIENT HAD A PRIMARY SURGERY ON (B)(6) 2024. ON (B)(6) 2024, THE PATIENT CAME IN REPORTING SIGNS OF INFECTION AND THE PATHOGEN WAS UNKNOWN. THE SURGEON PERFORMED A WASHOUT AND REVISED THE HEAD AND LINER. ON (B)(6) 2024, THE PATIENT CAME IN DUE TO SIGNS OF AN INFECTION AND THE PATHOGEN IS UNKNOWN. THE SURGEON REVISED ALL MEDACTA HARDWARE AND REIMPLANTED PERMANENT PRODUCT. THE SURGERY WAS COMPLETED SUCCESSFULLY.

  Patient problems: Unspecified Infection

  MAUDE report 20746318 ↗
• InjuryJul 16, 2024Malposition of Device; Malposition of Device

  AT 1 YEAR AND 4 MONTHS FROM THE PRIMARY, THE PATIENT CAME IN REPORTING PAIN DUE TO AN ANTEVERTED CUP. THE SURGEON REVISED THE MEDACTA CUP AND LINER WITH COMPETITOR COMPONENTS AND REVISED THE MEDACTA HEAD WITH A MEDACTA HEAD. THE SURGERY WAS COMPLETED SUCCESSFULLY.

  Patient problems: Pain

  MAUDE report 19749503 ↗
• InjuryJul 1, 2024Osseointegration Problem; Osseointegration Problem

  AT ABOUT 2 MONTHS AFTER PRIMARY, THE PATIENT CAME IN REPORTING PAIN DUE TO A LOOSE CUP AND THE CAUSE IS UNKNOWN. THE SURGEON REVISED THE CUP, HEAD AND LINER. THE SURGERY WAS COMPLETED SUCCESSFULLY.

  Patient problems: Implant Pain

  MAUDE report 19641720 ↗
• InjuryMar 28, 2024Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available

  AT 4 YEARS AND 3 MONTHS FROM THE PRIMARY, REVISION SURGERY DUE TO LEG LENGTH DISCREPANCY. THERE WAS <1MM LLD, BUT THE PATIENT WAS UNHAPPY. THEREFORE, THE SURGEON DECIDED TO REVISE THE CUP TO CHANGE THE OFFSET AND LEG LENGTH MARGINALLY. CUP, LINER AND FEMORAL HEAD COMPONENTS WERE REMOVED AND REPLACED WITH COMPETITOR'S COMPONENTS.

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available

  MAUDE report 18991056 ↗
• InjuryMar 8, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  AT ABOUT 1 YEAR AND 2 MONTHS AFTER PRIMARY, THE PATIENT CAME IN FOR A POST-OP APPOINTMENT AND POST OP X-RAYS INDICATED OSTEOLYSIS BEHIND THE ACETABULAR SHELL AND THE CAUSE IS UNKNOWN. THE SURGEON REVISED THE CUP, HEAD AND LINER. THE SURGERY WAS COMPLETED SUCCESSFULLY.

  Patient problems: Osteolysis

  MAUDE report 18865904 ↗
• InjuryDec 11, 2023Device Appears to Trigger Rejection; Device Appears to Trigger Rejection

  THE PATIENT CAME IN DUE TO SIGNS OF INFECTION AND THE PATHOGEN IS UNKNOWN. ABOUT 5 YEARS AND 4 MONTHS AFTER THE PRIMARY SURGERY, THE SURGEON REMOVED ALL IMPLANTS AND PLACED AN ANTIBIOTIC SPACER PER THE 2-STAGE INFECTION PROTOCOL. THE SURGERY WAS COMPLETED SUCCESSFULLY.

  Patient problems: Unspecified Infection

  MAUDE report 18299556 ↗
• InjuryAug 3, 2022Adverse Event Without Identified Device or Use Problem

  AT ABOUT 1 MONTH AFTER THE PRIMARY, THE PATIENT CAME IN DUE TO SIGNS OF AN INFECTION AND THE PATHOGEN IS UNKNOWN. THE SURGEON PERFORMED A WASHOUT AND REVISED ALL IMPLANTS. THE SURGERY WAS COMPLETED SUCCESSFULLY.

  Patient problems: Unspecified Infection

  MAUDE report 15156785 ↗
• InjuryOct 6, 2020Device Dislodged or Dislocated

  ABOUT 1 MONTH AFTER PRIMARY SURGERY THE PATIENT JOINT WAS REVISED FOR CUP DISLOCATION FROM THE ACETABULUM BONE. THE SURGEON REVISED SUCCESSFULLY THE PATIENT CUP AND LINER.

  Patient problems: No Code Available

  MAUDE report 10634597 ↗
• InjuryApr 17, 2020Malposition of Device; Malposition of Device

  REVISION SURGERY OF COMPETITOR IMPLANTS DUE TO STEM SUBSIDENCE AND FRACTURE (UNKNOWN WHICH IS THE MAIN REASON). COMPETITOR STEM HAS BEEN REVISED ON (B)(6) WITH ANTERIOR APPROACH. DURING SURGERY, THE FEMORAL FRACTURE WAS CABLED AND THE STEM REVISED AND, WHILE EXTERNALLY ROTATING AND LOWERING THE LEG TO PREPARE THE FEMUR, THE GT FRACTURED. THE SURGEON TRIED TO REPAIR THE FRACTURE BUT IT WAS TOO POSTERIOR SO HE DECIDED TO CABLE THE FRACTURE THE NEXT DAY, (B)(6). ANOTHER SURGERY WAS THEN PERFORMED ON MARCH 19 (ONE MONTH AFTER PRIMARY SURGERY) USING A POSTERIOR APPROACH TO REPAIR THE FRACTURE. CUP AND LINER HAVE BEEN REVISED DUE TO CUP MALPOSITIONING.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9971098 ↗
• InjuryJun 18, 2019Malposition of Device; Malposition of Device

  THE PATIENT CAME IN, 2 YEARS AND A HALF AFTER PRIMARY SURGERY, COMPLAINING OF PAIN DUE TO A MALPOSITION OF THE CUP. THE SURGEON REVISED THE MEDACTA CUP AND LINER WITH A COMPETITOR'S PRODUCT AND REVISED ANOTHER COMPANY'S HEAD WITH A MEDACTA HEAD. THE SURGERY WAS COMPLETED SUCCESSFULLY.

  Patient problems: Pain

  MAUDE report 8707243 ↗
• InjuryMay 27, 2019Appropriate Device Problem Term/Code Not Available

  THE PATIENT CAME IN COMPLAINING OF PAIN DUE TO THE MUSCLE RUBBING AGAINST THE CUP. THE SURGEON REAMED DEEPER AND REVISED THE 58MM MPACT 2-HOLE CUP WITH A 56MM MPACT MULTI-HOLE CUP. THE SURGEON ALSO REVISED THE HEAD AND LINER. THE SURGERY WAS COMPLETED SUCCESSFULLY.

  Patient problems: Pain

  MAUDE report 8644141 ↗
• InjuryMar 7, 2019Appropriate Device Problem Term/Code Not Available

  REVISION SURGERY 1 YEAR AND 3 MONTHS AFTER THE PRIMARY DUE TO INFECTION (THE PATHOGEN IS UNKNOWN). THE STEM, THE HEAD, THE LINER AND THE CUP HAVE BEEN REVISED AND ANTIBIOTIC SPACER HAS BEEN PLACED. THE SURGERY WAS COMPLETED SUCCESSFULLY.

  Patient problems: Unspecified Infection

  MAUDE report 8399591 ↗
• InjuryDec 5, 2018Appropriate Device Problem Term/Code Not Available

  POST-OP X-RAY REVEALED EXTREMELY VERTICAL CUP (INCLINATION OF AROUND 68 DEGREES), THE JOINT WAS STABLE AND THE SHELL WAS WELL FIXATED (GOOD PRIMARY STABILITY ACHIEVED INTRA OP), BUT THE SURGEON DECIDED TO REVISE THE IMPLANT ON (B)(46 2018 (7 DAYS AFTER PRIMARY SURGERY). REVISION THROUGH AMIS APPROACH WAS PERFORMED, MISPLACED 58 MM CUP WAS REMOVED, REAMING PERFORMED AND A NEW 60MM MPACT WAS IMPLANTED.

  Patient problems: No Code Available

  MAUDE report 8133921 ↗
• InjuryNov 22, 2018Device Dislodged or Dislocated

  TWO MONTHS AND A HALF AFTER PRIMARY, WHILE THE PATIENT WAS TYING THE SHOE, THE HIP DISLOCATED (LINER/HEAD FROM CUP). THE HIP WAS REDUCTED BUT THEN DISLOCATED A SECOND TIME, SO THE SURGEON REVISED THE IMPLANT. THE SURGEON WAS ADVISED BY ANOTHER ORTHOPEDIC SURGEON WHO HE WORKS WITH REGULARLY TO USE A MORE CONSTRAINED OPTION FOR THE CUP; THE SECOND SURGEON ASSISTED HIM DURING THE REVISION SURGERY AND OPTED TO USED ZIMMER CUP (WHICH IS WHAT HE WAS USED TO USING).

  Patient problems: Joint Dislocation

  MAUDE report 8098805 ↗
• InjuryNov 21, 2018Malposition of Device

  ON (B)(4) 2018 WE WERE INFORMED THAT ON THE FOLLOWING DAY, ABOUT 3 MONTHS AFTER PRIMARY, THE SURGEON WOULD HAVE REVISED THE PATIENT FOR A CUP MALPOSITIONING (POOR CUP POSITION PLACEMENT). ON (B)(6) 2018 THE SURGEON SWAPPED THE CUP, THE HEAD AND THE LINER. THE SURGERY WAS COMPLETED SUCCESSFULLY.

  Patient problems: No Code Available

  MAUDE report 8095221 ↗
• InjuryMar 1, 2018Contamination; Device Dislodged or Dislocated

  THE PATIENT CAME IN COMPLAINING OF PAIN. DUE TO THIS SIGN OF POSSIBLE INFECTION (PATHOGEN UNKNOWN), THE SURGEON REMOVED ALL COMPONENTS AND IMPLANTED A SPACER. IN ADDITION TO THE INFECTION, THE PATIENT HAD DISLOCATED.

  Patient problems: Joint Disorder; Unspecified Infection

  MAUDE report 7306122 ↗
• InjurySep 20, 2017Insufficient Device Problem Information

  THE PATIENT CAME IN DUE TO SIGNS OF INFECTION. THE PATHOGEN IS UNKNOWN. THE SURGEON REMOVED ALL MEDACTA HARDWARE. THE SURGEON IMPLANTED A SPACER. THE SURGERY WAS COMPLETED SUCCESSFULLY.

  Patient problems: Unspecified Infection

  MAUDE report 6878299 ↗