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 Type  malfunction  

Event Description

(b)(4).

Manufacturer Narrative

Batch review performed on (b)(6) 2015: lot #1413789: (b)(4) instruments manufactured and released on (b)(4) 2014.No anomalies found related to the problem.Lot #150076: (b)(4) shells manufactured and released on (b)(4) 2015.No anomalies found related to the problem.To date, (b)(4) shells of the lot have been already sold.On (b)(6) 2015, the (b)(4) made the following analysis upon inspection of the retrieved items: the terminal was manually disengaged from the cup with the screwdriver using a clamp to hold the cup.The contact surfaces between the two items do not present signs of seizing or excessive wear.

Manufacturer Narrative

On 07 september 2015 it was prepared a final report with the information already submitted in the initial report.On the same day the report was sent to the initial reporter and the case was closed.

• 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 (Section G): MEDACTA INTERNATIONAL, SA; strada regina 6874; castel san pietro ; SZ
• Manufacturer Contact: erin baumstark ; 3128782381
• MDR Report Key: 4908860
• MDR Text Key: 6539207
• Report Number: 3005180920-2015-00140
• 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: Company Representative,company representative
• Type of Report: Initial
• Report Date: 10/07/2015

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?: No
• Device Operator: Other
• Initial Date Manufacturer Received: 06/10/2015
• Initial Date FDA Received: 07/09/2015
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 12/01/2014
• Is the Device Single Use?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1