MAUDE Adverse Event Report: DEPUY IRELAND - 9616671 PFC SIGMARP STB TB IN 4 10.0; SIGMA KNEE PRIMARY : KNEE TIBIAL INSERT

Catalog Number 962141

Device Problems Delivered as Unsterile Product (1421); Device Contamination with Chemical or Other Material (2944)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 04/09/2018

Event Type  malfunction  

Manufacturer Narrative

Product complaint # (b)(4).Investigation summary: evaluation of the returned device/packaging confirms the reported event.Depuy considers the investigation closed at this time.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.

Event Description

The insert box was opened and it was found that there was a hair visible inside the sterile aspect of the insert which was never opened.

• Brand Name: PFC SIGMARP STB TB IN 4 10.0
• Type of Device: SIGMA KNEE PRIMARY : KNEE TIBIAL INSERT
• Manufacturer (Section D): DEPUY IRELAND - 9616671; loughbeg ringaskiddy co.; cork ; EI
• Manufacturer (Section G): DEPUY IRELAND 9616671; loughbeg, ringaskiddy co.; cork ; EI
• Manufacturer Contact: chad gibson ; 700 orthopaedic dr.; warsaw, IN 46581-0988 ; 5743725905
• MDR Report Key: 7919274
• MDR Text Key: 122158115
• Report Number: 1818910-2018-70832
• Device Sequence Number: 1
• Product Code: NJL
• UDI-Device Identifier: 10603295241317
• UDI-Public: 10603295241317
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 09/17/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/28/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 962141
• Device Lot Number: 8446642
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/07/2018
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 09/17/2018
• Date Device Manufactured: 01/13/2017
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Age: 57 YR