MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA VERSAFITCUP CC TRIO FLAT PE LINER Ø 32 / E; HIP SHELL LINER

Model Number	01.26.3244STT
Health Effect - Clinical Code	Osteolysis (2377)
Date of Event	06/09/2022
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Batch review performed on (b)(6) 2022: lot 146002: 45 items manufactured and released on 31-oct-2014.Expiration date: 2019-09-30.No anomalies found related to the problem.To date, all items of the same lot have been sold without any similar reported event during the period of review.Visual inspection: from the received pieces, it was possible to note in the liner a visible ovalization of the internal seat for the femoral head; the removal screw was still inside the rim, and a check with the femoral ball head was performed, confirming the ovalization of the inner liner.The femoral head shows some scratches and surface damages, potentially compatible with the presence in articulation of a small, hard object.The most relevant finding from the explants is an evident deformation of the internal liner; a possible root cause of the event can be polyethylene wear enhanced by a third body trapped in articulation, but it is difficult to determine it with certainty.
Event or Problem Description
At about 7 years after the primary, the patient came in reporting pain in the hip.Revision surgery was performed and it was discovered eccentric wear of the liner with subsequent osteolysis.

• Brand Name: VERSAFITCUP CC TRIO FLAT PE LINER Ø 32 / E
• Common Device Name: HIP SHELL LINER
• 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: 15025736
• Report Number: 3005180920-2022-00529
• Device Sequence Number: 12476867
• Product Code: LZO
• UDI-Device Identifier: 07630030807589
• UDI-Public: 07630030807589
• Combination Product (Y/N): N
• Initial Reporter Country: SZ
• PMA/510(K) Number: K103352
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Explanted Year: 2022
• 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): 07/15/2022

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: 09/30/2019
• Device Model Number: 01.26.3244STT
• Device Catalogue Number: 01.26.3244STT
• Device Lot Number: 146002
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/17/2022
• Initial Report FDA Received Date: 07/15/2022
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 10/31/2014
• 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