MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA CUP: VERSAFITCUP CC TRIO ACETABULAR SHELL CC TRIO 46

Model Number	01.26.45.0046
Medical Device Problem Code	Loosening of Implant Not Related to Bone-Ingrowth (4002)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	06/02/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Batch review performed on (b)(6) 2020.Lot 1901410: 180 items manufactured and released on (b)(6) 2019.Expiration date: 2024-05-01.No anomalies found related to the problem.To date, 156 items of the same lot have been already sold without any other similar reported event.Clinical evaluation performed by medical affairs director: acetabular component revision surgery (cup, head and liner) performed 5 months after primary cementless total hip arthroplasty in a (b)(6) year old woman.Radiographic image provided shows suboptimal cup position suggesting implant mobilization.Signs of stem-cup impingement are visible on the explanted component.No immediate postoperative x-ray is available.On the basis of information received, it is not possible to determine if this occurred before or after cup mobilization.The reason of this event cannot be determined.Preliminary investigation performed by r&d project manager: signs of osteointegration on the outer shell and scratches due to removal process.Impingement area on ceramic liner.It is not possible to highlight an implant related failure root cause.
Event or Problem Description
The shell moved (reason unknown ) the surgeon decided to change cup, liner and the head 4 months and 4 days after primary.The surgery was completed successfully.
Additional Manufacturer Narrative
Visual inspection performed by r&d hip manager: the acetabular liner shows signs of possible impingement, which might be in line with the cup mobilization that caused the revision.Acetabular shell with residual ha and bone formation.

• Brand Name: CUP: VERSAFITCUP CC TRIO ACETABULAR SHELL CC TRIO 46
• Common Device Name: ACETABULAR SHELL
• Manufacturer (Section D): MEDACTA INTERNATIONAL SA; strada regina; castel san pietro, 6874 ; CH 6874
• MDR Report Key: 10223520
• Report Number: 3005180920-2020-00371
• Device Sequence Number: 536103
• Product Code: LZO
• UDI-Device Identifier: 07630030807749
• UDI-Public: 07630030807749
• 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: Non-Healthcare Professional
• 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: Health Professional
• Device Expiration Date: 05/01/2024
• Device Model Number: 01.26.45.0046
• Device Catalogue Number: 01.26.45.0046
• Device Lot Number: 1901410
• 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: 06/02/2020
• Supplement Date Received by Manufacturer: 06/02/2020
• Initial Report FDA Received Date: 07/02/2020
• 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: 58 YR