MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US PFC*SIGMA C/S(PS)BOX TRIAL SZ5; KNEE INSTRUMENT : FEMORAL TRIALS

Model Number 96-1045

Device Problem Component Missing (2306)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 01/01/2020

Event Type  malfunction  

Manufacturer Narrative

Product complaint # (b)(4).If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

Event Description

The screw, which allows to maintain the test block, does not have a stopper as usual.Once the screw goes out, it is impossible to replace it.

Manufacturer Narrative

Product complaint # (b)(4).Mfr# is being retracted since it was found to be a duplicate report of mfr# 1818910-2020-18246.Mfr# 1818910-2020-18246 will be kept for investigation purposes.

• Type of Device: KNEE INSTRUMENT : FEMORAL TRIALS
• Manufacturer (Section D): DEPUY ORTHOPAEDICS INC US; 700 orthopaedic drive; warsaw IN 46581 0988
• MDR Report Key: 10403306
• MDR Text Key: 202805316
• Report Number: 1818910-2020-18088
• Device Sequence Number: 1
• Product Code: LXH
• UDI-Device Identifier: 10603295234739
• UDI-Public: 10603295234739
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 08/04/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/13/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 96-1045
• Device Catalogue Number: 961045
• Device Lot Number: SO2045192
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 08/17/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1