MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS, INC. SIG HP BASE FEMUR & TIBIA CASE; KNEE INSTRUMENT/TRIAL

Catalog Number 950502800

Device Problem Delamination (2904)

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

Event Date 03/06/2017

Event Type  malfunction  

Manufacturer Narrative

(b)(4).This complaint is still under investigation.Depuy will notify the fda of the results of this investigation once it has been completed.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

Event Description

Plastic coating is flaking off inside trays.

Manufacturer Narrative

Examination of the submitted device confirmed the reported bracket damage.Depuy considers the investigation closed.Should additional information be received, the information will be reviewed and the investigation will be re-opened as necessary.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

• Brand Name: SIG HP BASE FEMUR & TIBIA CASE
• Type of Device: KNEE INSTRUMENT/TRIAL
• Manufacturer (Section D): DEPUY ORTHOPAEDICS, INC.; 700 orthopaedic drive; warsaw IN 46582
• Manufacturer (Section G): DEPUY ORTHOPAEDICS, INC.; 700 orthopaedic drive; warsaw IN 46582
• Manufacturer Contact: chad gibson ; 700 orthopaedic drive; warsaw, IN 46581 ; 5743725905
• MDR Report Key: 6430502
• MDR Text Key: 70738671
• Report Number: 1818910-2017-15267
• Device Sequence Number: 1
• Product Code: FSM
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,health profession
• Reporter Occupation: Health Professional
• Type of Report: Initial,Followup
• Report Date: 03/06/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/23/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 950502800
• Device Lot Number: DR3A44
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/31/2017
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 05/01/2017
• 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: Unknown
• Patient Sequence Number: 1
• Patient Age: 62 YR