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

Device Problem Disconnection (1171)

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

Event Date 03/10/2015

Event Type  malfunction  

Event Description

Imp ref#: (b)(4).

Manufacturer Narrative

The lot of the instrument is unk and we are waiting for the retrieved items to make it available.Batch review performed on 04/09/2015 on the lot of the shell: lot 145994: (b)(4) shells produced and released on 11/17/2014.No anomalies found related to the problem.To date, (b)(4) shells of the lot have been already sold without any similar issue.

Manufacturer Narrative

On 07/02/2015 it was prepared a final report with the information collected during the investigation, already reported in the initial report and in the first follow up.On 07/09/2015 the report was sent to the initial reporter and the case was closed.

Manufacturer Narrative

Additional information: on 04/20/2015 the retrieved items have been disassembled and the lot of the instrument has been detected: 1213128.On this date, the r and d project manager analyzed the items with the following outcomes: the terminal was blocked into the cup because the thread was damaged likely due to a hit.The damaged thread compromises the coupling with the cup.

• Brand Name: TERMINAL CUP IMPACTOR FOR METAL BACK CC
• Type of Device: SURGICAL INSTRUMENT FOR HIP
• Manufacturer (Section D): MEDACTA INTERNATIONAL, SA; castel san pietro ; SZ
• Manufacturer Contact: erin baumstark ; strada regina; castel san pietro 6874 ; SZ 6874 ; 3128782381
• MDR Report Key: 4707571
• MDR Text Key: 21118611
• Report Number: 3005180920-2015-00052
• Device Sequence Number: 1
• Product Code: LXH
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Distributor
• 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
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 03/10/2015
• Initial Date FDA Received: 04/09/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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
• Treatment: VERSAFITCUP CC TRIO ACETABULAR SHELL:; K103352, CODE: 01.26.45.0058, LOT: 145994
• Patient Outcome(s): Other