MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US SIG C/R POROCOAT FEM LT SZ 4; SIGMA KNEE PRIMARY : KNEE FEMORAL

Model Number 94-0014

Device Problems Incorrect Measurement (1383); Defective Device (2588)

Patient Problems Not Applicable (3189); No Code Available (3191)

Event Date 02/28/2020

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

It is the speculation of the surgeon based on how the trial femur fit that the implant's porocoat was manufactured out of tolerance.

Manufacturer Narrative

Product complaint # : (b)(4).Investigation summary: the received device was forwarded to commercialized product development for evaluation.Review of the received device was unable to confirm the reported event.The investigation found no evidence of product malfunction or product error and the need for corrective action was not established.Depuy synthes considers the investigation closed at this time.Should additional information be received, the information will be reviewed and the investigation may be re-opened as necessary.

Event Description

Additional information received.Surgery delay about 20 minutes.

• Brand Name: SIG C/R POROCOAT FEM LT SZ 4
• Type of Device: SIGMA KNEE PRIMARY : KNEE FEMORAL
• Manufacturer (Section D): DEPUY ORTHOPAEDICS INC US; 700 orthopaedic drive; warsaw IN 46581 0988
• MDR Report Key: 9885453
• MDR Text Key: 188196975
• Report Number: 1818910-2020-09417
• Device Sequence Number: 1
• Product Code: JWH
• UDI-Device Identifier: 10603295223405
• UDI-Public: 10603295223405
• Combination Product (y/n): N
• PMA/PMN Number: K062654
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial,Followup
• Report Date: 02/28/2020

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
• Device Model Number: 94-0014
• Device Catalogue Number: 940014
• Device Lot Number: J3463W
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/14/2020
• Initial Date Manufacturer Received: 02/28/2020
• Initial Date FDA Received: 03/26/2020
• Supplement Dates Manufacturer Received: 06/12/2020
• Supplement Dates FDA Received: 06/18/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 71 YR