MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA CUP: VERSAFITCUP CC TRIO ACETABULAR SHELL 48

Model Number	01.26.45.0048
Medical Device Problem Code	Malposition of Device (2616)
Health Effect - Clinical Code	Joint Dislocation (2374)
Date of Event	04/18/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Batch review performed on 12 may 2021: lot 2007402: (b)(4) items manufactured and released on 05-nov-2020.Expiration date: 2025-11-03.No anomalies found related to the problem.To date, (b)(4) items of the same lot have been already sold without any other similar reported event clinical evaluation performed by medacta medical affairs department: postoperative hip dislocation in a (b)(6) year old heavy woman ((b)(6) kg).In the radiographic images provided the position of acetabular cup appears to be inadequate.We cannot tell if this is the result of post-surgery migration or the surgeon's choice: in the latter case, no explanation for this decision was supplied.In these conditions, it is very likely that part of the femoral stem may impinge with the acetabular rim and therefore dislocation occurs.The cause of dislocation should be defined as cup position.The cause for such cup position is unknown.
Event or Problem Description
Revision surgery performed due to dislocation (head from the liner) due to malposition of the cup (extreme anteversion of more than 60 degrees).The acetabular hardware was revised through the amis approach 10 days after the primary surgery.

• Brand Name: CUP: VERSAFITCUP CC TRIO ACETABULAR SHELL 48
• Common Device Name: ACETABULAR SHELL
• Manufacturer (Section D): MEDACTA INTERNATIONAL SA; strada regina; castel san pietro, 6874 ; SZ 6874
• MDR Report Key: 11847273
• Report Number: 3005180920-2021-00383
• Device Sequence Number: 3724295
• Product Code: LZO
• UDI-Device Identifier: 07630030807756
• UDI-Public: 07630030807756
• Combination Product (Y/N): N
• Initial Reporter Country: IS
• PMA/510(K) Number: K103352
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2021
• Device Explanted Year: 2021
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: distributor
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 05/19/2021

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: 11/03/2025
• Device Model Number: 01.26.45.0048
• Device Catalogue Number: 01.26.45.0048
• Device Lot Number: 2007402
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/19/2021
• Initial Report FDA Received Date: 05/19/2021
• 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: 65 YR
• Patient Weight: 84