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

Device Problems Entrapment of Device (1212); Sticking (1597)

Patient Problem No Information (3190)

Event Type  malfunction  

Event Description

Ref imp# (b)(4).

Manufacturer Narrative

Batch reviews: from the document review of the lot involved (1210174-27 instruments produced) no anomalies were found.No similar issues have been registered with items of the same lot.Versafitcup cc trio acetabular shell (k122911: code 01.26.45.1154 lot 140089: (b)(4)shells manufactured and (b)(4)already sold.No anomalies were found from the document review; no similar cases with items of the same lot.The failure mode is unlikely to cause pt harm, even if it can lead to additional steps to fix the problem.

• Brand Name: VERSAFITCUP CC TERMINAL CUP IMPACTOR
• Type of Device: REUSABLE SURGICAL INSTRUMENT FOR HIP
• Manufacturer (Section D): MEDACTA INTERNATIONAL SA; castel san pietro ; SZ
• Manufacturer (Section G): MEDACTA INTERNATIONAL SA; strada regina; castel san pietro 6874 ; SZ 6874
• Manufacturer Contact: adam gross ; 1556 w carrol ave; chicago, IL 60607 ; 3128782381
• MDR Report Key: 3888124
• MDR Text Key: 4539778
• Report Number: 3005180920-2014-00068
• Device Sequence Number: 1
• Product Code: MEH
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Company Representative
• Type of Report: Initial

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/04/2014
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: No
• Device Operator: Other
• Date Manufacturer Received: 05/08/2014
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 07/01/2012
• Is the Device Single Use?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1