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	Loosening of Implant Not Related to Bone-Ingrowth (4002)
Health Effect - Clinical Codes	Metal Related Pathology (4530); Aseptic loosening (4883)
Date of Event	01/20/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
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.
Additional Manufacturer Narrative
Batch review performed on 26 january 2026.Ball heads: cocr 01.25.031 cocr ball head 12/14 d 36 mm size m (k080885) lot 148649: (b)(4) items manufactured and released on 25-march-2015.Expiration date: 2020-01-31.No anomalies found related to the problem.To date, (b)(4) items of the same lot have been sold with no similar reported events during the period of review.Cup: versafitcup cc trio 01.26.45.0052 versafitcup metalback cc trio d 52 mm (k103352) lot 151063: (b)(4) items manufactured and released on 27-may-2015.Expiration date: 2020-04-30.No anomalies found related to the problem.(to date, (b)(4) items of the same lot have been sold with no similar reported events during the period of review.Root cause: based on the information available no definitive root cause can be established, while there is no indication that any potential issue with the device may have caused or contributed to the event, and the device history record review does not indicate any potential manufacturing related issue.

• 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 6874 ; SZ 6874
• Manufacturer Contact: marco giannessi ; strada regina; castel san pietro 6874 ; SZ 6874
• MDR Report Key: 24276574
• Report Number: 3005180920-2026-00087
• Device Sequence Number: 8569402
• Product Code: JDI
• UDI-Device Identifier: 07630030805219
• UDI-Public: 07630030805219
• Combination Product (Y/N): N
• PMA/510(K) Number: K080885
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2015
• Device Explanted Year: 2026
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 02/06/2026

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 Expiration Date: 01/31/2020
• Device Model Number: 01.25.031
• Device Lot Number: 148649
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/20/2026
• Initial Report FDA Received Date: 02/06/2026
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 03/25/2015
• 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: Unknown