MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA COCR FEMORAL BALL HEAD; COCR BALL HEAD 12/14 Ø28 MM SIZE L

Model Number	01.25.013
Medical Device Problem Code	Device Appears to Trigger Rejection (1524)
Health Effect - Clinical Code	Metal Related Pathology (4530)
Date of Event	10/01/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Batch review performed on 13-10-2025.Cocr 01.25.013 cocr ball head 12/14 ø28 mm size l (k072857) lot.092186: (b)(4) manufactured and released on 29-oct-2009 expiration date: 2014-08-31.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.Liner: versafitcup dm 01.26.2856mhc double mobility hc liner ø28/dmh (k092265) lot.091558: (b)(4) manufactured and released on 24-mar-2010 expiration date: 2014-05-31.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.Stem: amistem h 01.18.135 amistem-h std.Size 5 (k093944) lot.092522: (b)(4) manufactured and released on 11-12-2009 expiration date: 2014-oct-31.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.Due to the lack of information, it is not possible to establish a definitive root cause, while the device history record review does not indicate any potentially related manufacturing issue.
Event or Problem Description
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.

• Brand Name: COCR FEMORAL BALL HEAD
• Common Device Name: COCR BALL HEAD 12/14 Ø28 MM SIZE L
• 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: 23434015
• Report Number: 3005180920-2025-01042
• Device Sequence Number: 8625841
• Product Code: JDI
• UDI-Device Identifier: 07630030805127
• UDI-Public: 07630030805127
• Combination Product (Y/N): N
• Initial Reporter State: MO
• Initial Reporter Country: US
• PMA/510(K) Number: K072857
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2010
• Device Explanted Year: 2025
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 10/31/2025

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 Expiration Date: 10/29/2009
• Device Model Number: 01.25.013
• Device Lot Number: 092186
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/01/2025
• Initial Report FDA Received Date: 10/31/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 10/29/2009
• 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 Age: 80 YR
• Patient Sex: Male