MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA CUP: VERSAFITCUP CC TRIO ACETABULAR SHELL NO-HOLE 50; ACETABULAR SHELL NO HOLE

Model Number	01.26.45.1150
Health Effect - Clinical Code	Pain (1994)
Date of Event	03/11/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Batch review performed on 23 march 2021: lot 1906924: 225 items manufactured and released on 14-nov-2019.Expiration date: 2024-10-29.No anomalies found related to the problem.To date, 220 items of the same lot have been already sold without any similar reported event.Clinical evaluation performed by medacta medical affairs département: early onset of generalized pain, 1 year after primary cementless tha.The reason could not be explained.We did not get proper radiographs, so component fitting and sizing could not be judged.There is a reported doubt of infection, which could be a reasonable explanation.All implants were changed, but no determination of the cause of pain was reached.We can draw no conclusion on this event.No evidence of malfunctioning devices.Other devices involved: batch review performed on 23 march 2021: liner: versafitcup cc trio 01.26.3244hct flat pe hc liner ø 32 / e (k103352)lot.1906153: 168 items manufactured and released on 31-july-2019.Expiration date: 2024-07-17.No anomalies found related to the problem.To date, 166 items of the same lot have been already sold without any similar reported event.Stem: quadra-h 01.12.020 cementless, ha coated std stem size 0 (k082792)lot.1906960: 66 items manufactured and released on 13-nov-2019.Expiration date: 2024-11-04.No anomalies found related to the problem.To date, 47 items of the same lot have been already sold without any similar reported event.Ball heads: mectacer 01.29.205 biolox delta ceramic ball head 12/14 ø 32 size m 0 (k112115)lot.1907346: 269 items manufactured and released on 21-jan-2020.Expiration date: 2025-01-08.No anomalies found related to the problem.To date, 252 items of the same lot have been already sold without any similar reported event.
Event or Problem Description
Revision surgery 1 year after primary for hip pain during walking.All implant revised successfully.The reason of pain is unknown.

• Brand Name: CUP: VERSAFITCUP CC TRIO ACETABULAR SHELL NO-HOLE 50
• Common Device Name: ACETABULAR SHELL NO HOLE
• Manufacturer (Section D): MEDACTA INTERNATIONAL SA; strada regina; castel san pietro, 6874 ; SZ 6874
• MDR Report Key: 11641923
• Report Number: 3005180920-2021-00281
• Device Sequence Number: 2987904
• Product Code: LZO
• UDI-Device Identifier: 07630030807886
• UDI-Public: 07630030807886
• Combination Product (Y/N): N
• Initial Reporter Country: SZ
• PMA/510(K) Number: K122911
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2020
• Device Explanted Year: 2021
• 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): 04/09/2021

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: 10/29/2024
• Device Model Number: 01.26.45.1150
• Device Catalogue Number: 01.26.45.1150
• Device Lot Number: 1906924
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/11/2021
• Initial Report FDA Received Date: 04/09/2021
• 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: 55 YR