MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA VERSAFITCUP CC TRIO ACETABULAR SHELL CC TRIO 52

Model Number	01.26.45.0052
Health Effect - Clinical Code	Joint Disorder (2373)
Date of Event	05/15/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Batch review performed on 27 may 2020: lot 1906910: (b)(4) items manufactured and released on 24-oct-2019.Expiration date: 2024-10-12.No anomalies found related to the problem.To date, (b)(4) items of the same lot have been already sold without any similar reported event.Clinical evaluation: early acetabular component migration requiring revision surgery 3 months after primary total hip arthroplasty in a young patient ((b)(6) year old).The patient had sclerotic bone, which may have made preparation difficult: the reaming of the acetabulum may have ended up being insufficient, and the femoral stem may be undersized, although we have only one radiographic projection and this is not sufficient to properly evaluate.There is no reason to suspect a faulty device.
Event or Problem Description
Revision surgery 3 months after primary surgery for cup mobilization.The surgery was completed successfully, cup, liner and ceramic head swapped successfully.
Additional Manufacturer Narrative
Visual inspection performed by medacta r&d hip project manager: femoral head with signs of removal.Acetabluar shell with unknown residual on backside surface holes.Dark gray shadow-like aspect of unknown nature (might be metal debris) on the edge of the liner and both on the edge and backside surface of shell.It is not possible to determine failure root cause.

• Brand Name: VERSAFITCUP CC TRIO ACETABULAR SHELL CC TRIO 52
• Common Device Name: ACETABULAR SHELL
• Manufacturer (Section D): MEDACTA INTERNATIONAL SA; strada regina; castel san pietro, 6874, CHE; SZ 6874, CHE
• MDR Report Key: 10148612
• Report Number: 3005180920-2020-00329
• Device Sequence Number: 2420628
• Product Code: LZO
• UDI-Device Identifier: 07630030807770
• UDI-Public: 07630030807770
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• PMA/510(K) Number: K103352
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2020
• Device Explanted Year: 2020
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 08/28/2020

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: No Information
• Device Expiration Date: 10/12/2024
• Device Model Number: 01.26.45.0052
• Device Catalogue Number: 01.26.45.0052
• Device Lot Number: 1906910
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/30/2020
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/15/2020
• Supplement Date Received by Manufacturer: 05/15/2020
• Initial Report FDA Received Date: 06/12/2020
• Supplement Report FDA Received Date: 08/28/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 37 YR
• Patient Weight: 75