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

Model Number 01.26.58MB

Device Problem Difficult to Remove (1528)

Patient Problem No Code Available (3191)

Event Date 08/04/2020

Event Type  Injury  

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 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.

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
• Type of Device: ACETABULAR SHELL
• Manufacturer (Section D): MEDACTA INTERNATIONAL SA; strada regina; castel san pietro, 6874, CHE; SZ 6874, CHE
• MDR Report Key: 10487424
• MDR Text Key: 205470082
• Report Number: 3005180920-2020-00576
• Device Sequence Number: 1
• Product Code: MEH
• UDI-Device Identifier: 07630030808203
• UDI-Public: 07630030808203
• Combination Product (y/n): N
• PMA/PMN Number: K083116
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Type of Report: Initial,Followup
• Report Date: 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
• Device Operator: 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
• Initial Date Manufacturer Received: 08/04/2020
• Initial Date FDA Received: 09/03/2020
• Supplement Dates Manufacturer Received: 08/04/2020
• Supplement Dates FDA Received: 12/03/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other