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

Device Problem Separation Failure (2547)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 01/17/2019

Event Type  malfunction  

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 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
• Type of Device: SURGICAL INSTRUMENT FOR HIP SURGERY
• Manufacturer (Section D): MEDACTA INTERNATIONAL SA; strada regina; castel san pietro, switzerland 6874 ; SZ 6874
• Manufacturer (Section G): MEDACTA INTERNATIONAL SA; strada regina; castel san pietro, switzerland 6874 ; SZ 6874
• Manufacturer Contact: stefano baj ; strada regina; castel san pietro, switzerland 6874 ; SZ 6874
• MDR Report Key: 8343142
• MDR Text Key: 136732469
• Report Number: 3005180920-2019-00066
• Device Sequence Number: 1
• Product Code: LXH
• UDI-Device Identifier: 07630040781077
• UDI-Public: 07630040781077
• Combination Product (y/n): N
• Reporter Country Code: AU
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 02/15/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/15/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: 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
• Date Manufacturer Received: 01/18/2019
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/02/2010
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1
• Patient Outcome(s): Other