MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA CUP: VERSAFITCUP ACETABULAR SHELL Ø 50; HIP CEMENTLESS SHELL

Catalog Number	01.26.50MB
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	09/25/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Batch review performed on 06 november 2018: lot 176037: (b)(4) items manufactured and released on 01-feb-2018.Expiration date: 2023-01-23.No anomalies found related to the problem.To date, (b)(4) items of the same lot have been already sold without any similar reported event.Additional product involved: versafitcup dm 01.26.10.0135 impacting ring #50, lot 1415784: (b)(4) items manufactured and released on 10 july 2015.No anomalies found related to the issue.To date, no similar event on the same lot has been registered.Visual inspection performed on the retrieved instruments: the signs on the external diameter of the inspected impacting ring could have compromised the instrument functionality.Probably these signs were caused during the cleaning of the instrument.
Event or Problem Description
Hip replacement with a versafit dm.The reaming and the trial of the cup were done, finally, the cup versafit dm ø 50 was chosen as the definitive cup; the implant was coupled with the impact ring size 50 with its multifunctional impactor handle and the cup was impacted.When the impacting ring was going to be disassembled from the cup, this piece did not loosen; for that reason, the surgeon had to remove the cup with the related impact ring.The process was repeated and the same situation happened.Therefore, to position and impact the cup, the surgeon used the same multifunctional impactor handle with the correction impaction sphere ø 33 for metal back (ref.01.26.10.0017).

• Brand Name: CUP: VERSAFITCUP ACETABULAR SHELL Ø 50
• Common Device Name: HIP CEMENTLESS SHELL
• Manufacturer (Section D): MEDACTA INTERNATIONAL SA; strada regina; castel san pietro, switzerland 6874 ; SZ 6874
• MDR Report Key: 8041554
• Report Number: 3005180920-2018-00857
• Device Sequence Number: 16515276
• Product Code: MEH
• UDI-Device Identifier: 07630030808067
• UDI-Public: 07630030808067
• Combination Product (Y/N): N
• Initial Reporter Country: CO
• PMA/510(K) Number: K083116
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: distributor
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 11/06/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 01/23/2023
• Device Catalogue Number: 01.26.50MB
• Device Lot Number: 176037
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/29/2018
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/08/2018
• Initial Report FDA Received Date: 11/06/2018
• 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