CoCr Femoral Ball HeadRecalls & reported problems across all models

We found 15 models of CoCr Femoral Ball Head by Medacta International SA in the FDA's device registry (GUDID). Together they are named in 112 adverse event reports in the FDA's MAUDE database, received between Jul 12, 2017 and Jul 10, 2026 — classified as 110 injuries, 2 malfunctions.

The most frequently reported specific device problem is “Device Dislodged or Dislocated” (35 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. 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

Most reported CoCr Femoral Ball Head problems

CoCr Femoral Ball Head models

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

• CoCr Femoral Ball Head 01.25.012

  Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Cemented
  19 reports
• CoCr Femoral Ball Head 01.25.031

  Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Cemented
  16 reports
• CoCr Femoral Ball Head 01.25.014

  Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Cemented
  11 reports
• CoCr Femoral Ball Head 01.25.021

  Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Cemented
  11 reports
• CoCr Femoral Ball Head 01.25.123

  Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Cemented
  11 reports
• CoCr Femoral Ball Head 01.25.011

  Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Cemented
  10 reports
• CoCr Femoral Ball Head 01.25.022

  Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Cemented
  8 reports
• CoCr Femoral Ball Head 01.25.013

  Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Cemented
  5 reports
• CoCr Femoral Ball Head 01.25.015

  Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Cemented
  5 reports
• CoCr Femoral Ball Head 01.25.023

  Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Cemented
  4 reports
• CoCr Femoral Ball Head 01.25.030

  Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Cemented
  3 reports
• CoCr Femoral Ball Head 01.25.124

  Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Cemented
  3 reports
• CoCr Femoral Ball Head 01.25.032

  Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Cemented
  2 reports
• CoCr Femoral Ball Head 01.25.033

  Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Cemented
  2 reports
• CoCr Femoral Ball Head 01.25.034

  Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Cemented
  2 reports

Recent CoCr Femoral Ball Head adverse event reports

The 15 most recent reports across all models, in the reporter's own words as published by the FDA.

• InjuryJul 10, 2026Device Appears to Trigger Rejection

  REVISION SURGERY DUE TO INFECTION AFTER 26 DAYS FROM PRIMARY. THE SURGEON PERFORMED A WASHOUT AND REVISED THE 12/14 D 28 MM SIZE XL COCR HEAD TO A SAME SIZE HEAD, AND REVISED THE DOUBLE MOBILITY HC LINER D 28/DME TO A SAME SIZE LINER.

  Patient problems: Medical device site infection

  MAUDE report 25778112 ↗
• InjuryApr 14, 2026Adverse Event Without Identified Device or Use Problem

  AT ABOUT (B)(6) AFTER THE PRIMARY, THE PATIENT CAME IN PRESENTING INSTABILITY DUE TO A GAP FORMING BETWEEN THE HEAD AND LINER. THE CAUSE IS UNKNOWN AS THERE WAS NO REPORTED TRAUMA. THE SURGEON REVISED THE MEDACTA CUP AND LINER TO A COMPETITOR CUP AND LINER AND REVISED THE MEDACTA 36MM HEAD TO A 28MM HEAD WITH SLEEVE. THE SURGERY WAS COMPLETED SUCCESSFULLY.

  Patient problems: Joint Laxity

  MAUDE report 24871649 ↗
• InjuryMar 10, 2026Device Appears to Trigger Rejection

  AT ABOUT 2 MONTH FROM THE PRIMARY, THE PATIENT CAME IN DUE TO SIGNS OF INFECTION AND THE PATHOGEN IS UNKNOWN. THE SURGEON PERFORMED A WASHOUT, REVISED THE D 28MM COCR SIZE M HEAD TO A D 28MM COCR SIZE L AT THE SURGEON`S DISCRETION, AND REVISED THE D 28X53 BIOPOLAR HEAD TO A BIOPOLAR HEAD OF THE SAME SIZE. THE SURGERY WAS COMPLETED SUCCESSFULLY.

  Patient problems: Medical device site infection

  MAUDE report 24558202 ↗
• InjuryMar 3, 2026Device Dislodged or Dislocated

  REVISION SURGERY WAS PERFORMED DUE TO INSTABILITY AND DISLOCATION. AT ABOUT 6 MONTHS FROM PRIMARY THE SURGEON REVISED THE HEAD TO ONE OF COMPETITOR.

  Patient problems: Joint Dislocation

  MAUDE report 24494919 ↗
• InjuryFeb 6, 2026Loosening of Implant Not Related to Bone-Ingrowth

  AT ABOUT 10 YEARS 5 MONTHS AFTER THE PRIMARY, THE PATIENT CAME IN REPORTING PAIN DUE TO METALLOSIS. THE SURGEON ALSO OBSERVED THAT THE CUP WAS LOOSE. THE SURGEON REVISED THE CUP, LINER, AND HEAD. THE SURGERY WAS COMPLETED SUCCESSFULLY.

  Patient problems: Aseptic loosening; Metal Related Pathology

  MAUDE report 24276574 ↗
• InjuryDec 23, 2025Device Appears to Trigger Rejection; Device Appears to Trigger Rejection

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

  Patient problems: Medical device site infection

  MAUDE report 23876943 ↗
• InjuryDec 18, 2025Device Dislodged or Dislocated; Device Dislodged or Dislocated

  THE PATIENT HAD PRIMARY LEFT HIP SURGERY ON (B)(6) 2016. ON (B)(6) 2024, THE PATIENT CAME IN REPORTING PAIN DUE TO A DISLOCATION OF THE HEAD FROM THE LINER AND THE CAUSE IS UNKNOWN. THE SURGEON REVISED THE HEAD AND LINER. THE SURGERY WAS COMPLETED SUCCESSFULLY. ON (B)(6) 2025, THE PATIENT CAME IN REPORTING PAIN DUE TO A DISLOCATION OF THE HEAD FROM THE LINER AND THE CAUSE IS UNKNOWN. THE SURGEON REVISED THE BIOLOX HEAD AND HOODED LINER TO A COCR HEAD AND CONTRAINED LINER. THE SURGERY WAS COMPLETED SUCCESSFULLY. PRESENTLY, ON (B)(6) 2025, THE PATIENT CAME IN DUE TO INTRA-PROSTHETIC DISLOCATION, WHERE THE COCR HEAD HAD DISENGAGED FROM THE BIPOLAR COMPONENT. THE SURGEON REPORTED THAT DURING THE INITIAL IMPLANTATION, THERE WAS NO CLEAR TACTILE FEEDBACK OR CONFIRMATION OF FULL ENGAGEMENT, AND HE HAD NOTICED THE HEAD APPEARING SLIGHTLY DISPLACED FROM THE BIPOLAR COMPONENT. THE CONSTRAINED LINER AND METAL HEAD WERE REMOVED AND REPLACED WITH AN OFFSET D LINER AND A CERAMIC HEAD. THE SURGERY WAS COMPLETED SUCCESSFULLY.

  Patient problems: Joint Dislocation

  MAUDE report 23837281 ↗
• InjuryDec 18, 2025Device Appears to Trigger Rejection; Device Appears to Trigger Rejection

  FIVE MONTHS AFTER THE PRIMARY SURGERY, THE PATIENT REPORTED PERSISTENT PAIN AND SWELLING. A NICKEL ALLERGY WAS DIAGNOSED. BASED ON THIS AND THE X-RAY FINDINGS, A REVISION WAS PERFORMED. INTRAOPERATIVELY, THE STEM WAS STABLE, SO ONLY THE HEAD WAS EXCHANGED WITH A BIOLOX OPTION.

  Patient problems: Metal Related Pathology

  MAUDE report 23836916 ↗
• InjuryOct 31, 2025Device Appears to Trigger Rejection; Device Appears to Trigger Rejection

  AT ABOUT 15 YEARS AND 5 MONTHS FROM PRIMARY THE PATIENT WAS REVISED DUE TO SUSPECTED POLY LINER WEAR IDENTIFIED DURING CT EXAM, ALSO USE OF METAL HEAD LED TO SUSPECT TRUNNIONOSIS. DURING REVISION TRUNNIONOSIS WAS CONFIRMED WHILE THE LINER DID NOT SEEM TO BE TOO WORN. METAL HEAD WAS SUBSTITUTED WITH A CERAMIC ONE AND LINER WITH AN HC ONE. STEM WAS NOT REVISED. SURGERY COMPLETED SUCCESSFULLY.

  Patient problems: Metal Related Pathology

  MAUDE report 23434015 ↗
• InjuryOct 6, 2025Device Dislodged or Dislocated; Device Dislodged or Dislocated

  THE PATIENT HAD A PRIMARY HIP SURGERY ON 18 DEC 2019. SUBSEQUENTLY, THE HEAD DISLOCATED FROM THE LINER. ON (B)(6) 2022, THE SURGEON REVISED THE HEAD AND LINER. (B)(4). SUBSEQUENTLY, THE PATIENT CAME IN DUE TO SIGNS OF INFECTION AND THE PATHOGEN WAS UNKNOWN. ON (B)(6) 2022, THE SURGEON PERFORMED A WASHOUT AND REVISED THE HEAD AND LINER. (B)(4). SUBSEQUENTLY, THE PATIENT CAME IN DUE TO SIGNS OF INFECTION AND THE PATHOGEN WAS UNKNOWN. ON (B)(6) 2023, THE SURGEON PERFORMED A WASHOUT, REVISED ALL IMPLANTS. (B)(4). SUBSEQUENTLY, THE PATIENT CAME IN DUE TO SIGNS OF INFECTION AND THE PATHOGEN WAS UNKNOWN. ON 28 AUG 2023, THE SURGEON PERFORMED A WASHOUT, REVISED ALL IMPLANTS. (B)(4). SUBSEQUENTLY, THE PATIENT CAME IN DUE TO A DISLOCATION OF THE HEAD FROM THE LINER. ON (B)(6) 2023, THE SURGEON REVISED THE HEAD AND LINER AND IMPLANTED A DM CONVERTER. (B)(4). ON (B)(6) 2025, THE PATIENT CAME IN REPORTING PAIN DUE TO A DISLOCATION OF THE HEAD FROM THE LINER AND THE CAUSE IS UNKNOWN. ON (B)(6) 2025 THE SURGEON REVISED THE MEDACTA STEM WITH A COMPETITOR STEM, AND REVISED THE MEDACTA HEAD AND LINER TO A MEDACTA DM.

  Patient problems: Joint Dislocation

  MAUDE report 23221255 ↗
• InjurySep 2, 2025Device Appears to Trigger Rejection; Device Appears to Trigger Rejection

  AT ABOUT 2 WEEKS FROM PRIMARY, THE PATIENT CAME IN DUE TO SIGNS OF AN INFECTION AND THE PATHOGEN IS UNKNOWN. THE SURGEON PERFORMED A WASHOUT AND REVISED THE HEAD AND LINER. THE SURGERY WAS COMPLETED SUCCESSFULLY.

  Patient problems: Medical device site infection

  MAUDE report 22937397 ↗
• InjuryJul 23, 2025Device Dislodged or Dislocated; Device Dislodged or Dislocated

  AT ABOUT 3 MONTHS FROM THE PRIMARY SURGERY, THE PATIENT CAME IN REPORTING PAIN DUE TO A DISLOCATION OF THE MEDACTA HEAD FROM THE COMPETITOR LINER. THE SURGEON REVISED AND UPSIZED ONLY THE HEAD TO GIVE THE PATIENT STABILITY TO DETER RECURRING DISLOCATIONS. THE SURGERY WAS COMPLETED SUCCESSFULLY.

  Patient problems: Joint Dislocation; Pain

  MAUDE report 22573682 ↗
• InjuryJun 17, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  AT ABOUT 7 MONTHS FROM PRIMARY, THE PATIENT CAME IN REPORTING PAIN AND INSTABILITY DUE TO A LEG LENGTH DISCREPANCY AND LACK OF OFFSET. THE SURGEON REVISED THE HEAD AND LINER AND THE SURGERY WAS COMPLETED SUCCESSFULLY.

  Patient problems: Joint Laxity; Pain

  MAUDE report 22229294 ↗
• InjuryJan 24, 2025Device Appears to Trigger Rejection; Device Appears to Trigger Rejection

  THE PATIENT HAD A PRIMARY HIP SURGERY ON (B)(6) 2024. ON (B)(6) 2024, THE PATIENT CAME IN REPORTING PAIN DUE TO A DISLOCATION OF THE HEAD FROM THE LINER AND THE CAUSE WAS UNKNOWN. THE SURGEON REVISED HEAD, LINER AND DM CONVERTER. THE SURGERY WAS COMPLETED SUCCESSFULLY. MDR 3005180920-2024-01131. ON (B)(6) 2025 THE PATIENT CAME IN DUE TO SIGNS OF AN INFECTION AND THE PATHOGEN IS UNKNOWN. THE SURGEON PERFORMED A WASHOUT AND REVISED THE HEAD, LINER AND DM CONVERTER. THE SURGERY WAS COMPLETED SUCCESSFULLY.

  Patient problems: Unspecified Infection

  MAUDE report 21227335 ↗
• InjuryJan 16, 2025Device Dislodged or Dislocated; Device Dislodged or Dislocated

  THE PATIENT HAD A PRIMARY HIP SURGERY WITH A COMPETITOR ON AN UNKNOWN DATE. SUBSEQUENTLY, THE PATIENT CAME IN FOR AN UNKNOWN REASON AND THE SURGEON REVISED THE COMPETITOR HEAD TO A MEDACTA HEAD ON (B)(6) 2024. ON (B)(6) 2024 THE PATIENT HAD PAIN DUE TO A DISLOCATION OF THE MEDACTA HEAD FROM THE COMPETITOR LINER. THE SURGEON REVISED THE MEDACTA HEAD WITH ANOTHER MEDACTA HEAD AND REVISED THE COMPETITOR LINER WITH ANOTHER COMPETITOR LINER. THE SURGERY WAS COMPLETED SUCCESSFULLY.

  Patient problems: Implant Pain

  MAUDE report 21166549 ↗

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