MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA CUP: VERSAFITCUP ACETABULAR SHELL 58

Model Number	01.26.58MB
Health Effect - Clinical Code	No Code Available (3191)
Date of Event	08/04/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Batch review performed by medacta regulatory affairs department on 13.08.2020: lot 160207: (b)(4) items manufactured and released on 2-may-2016.Expiration date: 2021-04-18.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.Other device involved in the event: cup: versafitcup cc trio 01.26.45.1158 acetabular shell cc trio no-hole ø 58 lot.2000144 (k122911).Batch review performed by medacta regulatory affairs department on 13.08.2020: lot 2000144 : (b)(4) items manufactured and released on 30-apr-2020.Expiration date: 2025-04-20.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.
Event or Problem Description
The surgeon wanted to implant a versafitcup dm s58 and after he had a press-fit the impacting ring did not come off.By trying several times afterward also with a versafitcup cc trio he had to cement a new one- apricot.The bone structure was damaged.The surgeon cemented a new cup on the bone damage.
Additional Manufacturer Narrative
Visual inspection: it is possible that a sizing occurred due to an incorrect usage: - wrong screwing of the shell versaficup #58 dm ref.01.26.10.0139 with the impacting ring #58 ref.01.26.10.0139.

• Brand Name: CUP: VERSAFITCUP ACETABULAR SHELL 58
• Common Device Name: ACETABULAR SHELL
• Manufacturer (Section D): MEDACTA INTERNATIONAL SA; strada regina; castel san pietro, 6874, CHE; SZ 6874, CHE
• MDR Report Key: 10487424
• Report Number: 3005180920-2020-00576
• Device Sequence Number: 19471060
• Product Code: MEH
• UDI-Device Identifier: 07630030808203
• UDI-Public: 07630030808203
• Combination Product (Y/N): N
• Initial Reporter Country: SZ
• PMA/510(K) Number: K083116
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 12/03/2020

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: 04/18/2021
• Device Model Number: 01.26.58MB
• Device Catalogue Number: 01.26.58MB
• Device Lot Number: 160207
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/16/2020
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/04/2020
• Supplement Date Received by Manufacturer: 08/04/2020
• Initial Report FDA Received Date: 09/03/2020
• Supplement Report FDA Received Date: 12/03/2020
• 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: Other