MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA BALL HEADS: COCR 01.25.123 COCR BALL HEAD 12/14 Ø 22 SIZE M 0

Model Number	01.25.123
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	02/07/2022
Type of Reportable Event	Serious Injury
Event or Problem Description
Revision surgery at about 2 months from primary due to intraprostatic dislocation of the metal head from the double mobility liner.The surgery was completed successfully.
Additional Manufacturer Narrative
Batch review performed on 16 february 2022.Lot 188819: (b)(4) items manufactured and released on 28-jan-2019.Expiration date: 2024-01-16.No anomalies found related to the problem.To date, (b)(4) items of the same lot have been sold without any similar reported event.Visual inspection performed by (b)(4) project manager from the received pieces, the head is dislocated from the dm liner, while the dm liner shows clear signs on the base rim, probably occurred during impingement with the stem or during the revision.Quality control measurements were performed, revealing that the dimensions of the liner are in specification, so we can exclude a defect of the part.From the received information, we can not determine with certainty the root cause of the event, even if a possible cause can be related to an high lever arm applied to the head, that brought to the event.Other device involved: batch review performed on 16 february 2022.Liner: mpact 01.26.2246 mhc double mobility hc liner ø 46/22.2 (k092265) lot 1901453: (b)(4) items manufactured and released on 15-may-2019.Expiration date: 2024-05-05.No anomalies found related to the problem.To date, (b)(4) items of the same lot have been sold without any similar reported event.
Additional Manufacturer Narrative
On 21-march-2022 xrays analysis was performed.Clinical evaluation performed by medical affairs director hip intraprosthetic dislocation 1 month after index implantation.A dislocation occured of the femoral head from the double mobility liner.Dislocation of the head from the liner is usually caused by extreme positions when the movement of the mobile insert is impeded by surrounding tissues: in this case, the cup appears to be of significant size, markedly protruding from the acetabulum: a situation that was probably dictated by individual patient conditions (not visible in the postoperative xray) but that may imply limitations to the range of motion.The size of the modular head, 22mm, obviously commanded by the small size of the patient, is a further limiting factor for the final stability of the articulation.

• Brand Name: BALL HEADS: COCR 01.25.123 COCR BALL HEAD 12/14 Ø 22 SIZE M 0
• Common Device Name: COCR BALL HEAD
• Manufacturer (Section D): MEDACTA INTERNATIONAL SA; strada regina; castel san pietro, 6874 ; SZ 6874
• Manufacturer (Section G): MEDACTA INTERNATIONAL SA; strada regina; castel san pietro, 6874 ; SZ 6874
• Manufacturer Contact: stefano baj ; strada regina; castel san pietro, switzerland 6874 ; SZ 6874
• MDR Report Key: 13711507
• Report Number: 3005180920-2022-00157
• Device Sequence Number: 6286965
• Product Code: JDI
• UDI-Device Identifier: 07630030805479
• UDI-Public: 07630030805479
• Combination Product (Y/N): N
• Initial Reporter Country: SZ
• PMA/510(K) Number: K080885
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2021
• Device Explanted Year: 2022
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 04/08/2022

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: 01/16/2024
• Device Model Number: 01.25.123
• Device Catalogue Number: 01.25.123
• Device Lot Number: 188819
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/04/2022
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/07/2022
• Supplement Date Received by Manufacturer: 02/07/2022
• Initial Report FDA Received Date: 03/09/2022
• Supplement Report FDA Received Date: 04/08/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/28/2019
• 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: Female