MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA COCR FEMORAL BALL HEAD; COCR BALL HEAD 12/14 Ø36 MM SIZE M

Model Number	01.25.031
Medical Device Problem Code	Device Dislodged or Dislocated (2923)
Health Effect - Clinical Codes	Pain (1994); Joint Dislocation (2374)
Date of Event	07/08/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Batch review performed on 11-jul-2025.Ball heads: cocr 01.25.031 cocr ball head 12/14 ø36 mm size m (k080885) lot.186285b: 1 items manufactured and released on 28-nov-2023.Expiration date: 14-apr-2029.No anomalies found related to the problem.To date, all items of the same lot have been sold with no similar reported event during the period of review.
Event or Problem Description
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.

• Brand Name: COCR FEMORAL BALL HEAD
• Common Device Name: COCR BALL HEAD 12/14 Ø36 MM SIZE M
• Manufacturer (Section D): MEDACTA INTERNATIONAL SA; strada regina; castel san pietro, switzerland 6874 ; SZ 6874
• Manufacturer (Section G): MEDACTA INTERNATIONAL SA; strada regina; castel san pietro, switzerland 6874 ; SZ 6874
• Manufacturer Contact: marco giannessi ; strada regina; castel san pietro, switzerland 6874 ; SZ 6874
• MDR Report Key: 22573682
• Report Number: 3005180920-2025-00699
• Device Sequence Number: 13173384
• Product Code: JDI
• UDI-Device Identifier: 07630030805219
• UDI-Public: 07630030805219
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K080885
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2025
• Device Explanted Year: 2025
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 07/22/2025

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Model Number: 01.25.031
• Device Lot Number: 186285B
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 07/08/2025
• Initial Report FDA Received Date: 07/23/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 11/28/2023
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Male