MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA TERMINAL CUP IMPACTOR FOR METAL BACK CC; SURIGAL INSTRUMENT FOR HIP

Catalog Number 01.15.10.0261

Device Problem Disconnection (1171)

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

Event Date 03/10/2015

Event Type  malfunction  

Event Description

After the fixation into the acetabulum of the versafitcup cc trio size 58 it was not possible to disconnect the cup-impactor-adapter from the cup.After removing of the cup including the adapter, they changed the size to 60 and finished the surgery with another cup impactor.Mfr ref#: 3005180920-2015-00052.

• Brand Name: TERMINAL CUP IMPACTOR FOR METAL BACK CC
• Type of Device: SURIGAL INSTRUMENT FOR HIP
• Manufacturer (Section D): MEDACTA INTERNATIONAL SA; castel san pietro ; SZ
• MDR Report Key: 4707671
• MDR Text Key: 5723099
• Report Number: 3006639916-2015-00052
• Device Sequence Number: 1
• Product Code: LXH
• Combination Product (y/n): N
• Reporter Country Code: GM
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Distributor
• Source Type: Unknown
• Reporter Occupation: Not Applicable
• Type of Report: Initial
• Report Date: 04/09/2015

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
• Device Operator: Health Professional
• Device Catalogue Number: 01.15.10.0261
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 04/09/2015
• Distributor Facility Aware Date: 04/09/2015
• Event Location: Hospital
• Date Report to Manufacturer: 04/09/2015
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 04/09/2015
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: K103352, CODE: 01.26.45.0058, LOT:145994; VERSAFITCUP CC TRIO ACETABULAR SHELL:
• Patient Outcome(s): Other