MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA VERSAFITCUP CC 01.26.10.0062 VERSAFITCUP CC CUP IMPACTOR; SURGICAL INSTRUMENT FOR HIP SURGERY

Catalog Number	01.26.10.0062
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	01/17/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Batch review performed on 11 february 2019: lot 105494: (b)(4) items manufactured and released on 02-sep-2010.No anomalies found related to the problem.To date, no similar event has been reported.Visual inspection performed by r&d project manager: the handle was stuck in the cup, it was necessary to block the cup in a clamp to disassemble the pieces.There was some coagulated blood between the threads of the pieces.It might be possible that coagulated blood blocked the cup, but we do not know if it happened during the surgery.
Event or Problem Description
During cup impaction with the straight cup-impactor, the surgeon was not able to release the impactor from the implanted cup.They explanted the cup with the "cold-welded" impactor.A back-up instrument and cup were used to complete successfully the surgery.

• Brand Name: VERSAFITCUP CC 01.26.10.0062 VERSAFITCUP CC CUP IMPACTOR
• Common Device Name: SURGICAL INSTRUMENT FOR HIP SURGERY
• Manufacturer (Section D): MEDACTA INTERNATIONAL SA; strada regina; castel san pietro, switzerland 6874 ; SZ 6874
• MDR Report Key: 8343142
• Report Number: 3005180920-2019-00066
• Device Sequence Number: 2138495
• Product Code: LXH
• UDI-Device Identifier: 07630040781077
• UDI-Public: 07630040781077
• Combination Product (Y/N): N
• Initial Reporter Country: AU
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 02/15/2019

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 Catalogue Number: 01.26.10.0062
• Device Lot Number: 105494
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/30/2019
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/18/2019
• Initial Report FDA Received Date: 02/15/2019
• 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