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

Catalog Number 01.15.10.0261

Device Problems Break (1069); Disconnection (1171)

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

Event Date 07/03/2018

Event Type  malfunction  

Manufacturer Narrative

Batch review performed on 26 july 2018: lot 1413789: (b)(4) items manufactured and released on 15 december 2014.No anomalies found related to the problem.To date, this is the first similar event reported on items of the same lot.Visual inspection performed on 25 july 2018 by r&d product manager: during the analysis it is evaluated that the terminal is screwed inside the cup.It is unscrewed using the screwdriver ref (b)(4).Looking at the terminal surface it is evaluated that the balint coating is scratched.In addition also the threaded part is scratched.There are also some scratches on the cup surface.It is possible to suppose that the scratch of the balint coating caused the block of the terminal inside the cup.

Event Description

The terminal disassembled from the cup.The thread of the cup is damaged.The surgeon implanted a new versafit cup cc trio using the straight impactor.

• Brand Name: AMIS TERMINAL CUP IMPACTOR FOR METAL BACK CC
• Type of Device: SURGICAL INSTRUMENT FOR HIP
• 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: 7726657
• MDR Text Key: 115534094
• Report Number: 3005180920-2018-00559
• Device Sequence Number: 0
• Product Code: LXH
• Reporter Country Code: GM
• 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: 07/27/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/27/2018
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 01.15.10.0261
• Device Lot Number: 1413789
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/15/2014
• Date Manufacturer Received: 07/03/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 12/15/2014
• 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