MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US PFC SIGMARP STB TB IN 2 12.5; SIGMA KNEE PRIMARY : KNEE TIBIAL INSERT

Catalog Number	962112
Medical Device Problem Code	Naturally Worn (2988)
Health Effect - Clinical Codes	Rheumatoid Arthritis (1724); No Code Available (3191)
Date of Event	12/21/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.
Event or Problem Description
It was reported that sigma ps/rp revision synovectomy insert exchange was done secondary to rheumatoid arthritis.Insert explant shows significant oxidation and wear.Explant to be returned.Post was cut by surgeon during removal.
Additional Manufacturer Narrative
Product complaint # (b)(4).Investigation summary: examination of the reported device confirmed the reported wear.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.If information is obtained that was not available for the initial medwatch ,a follow-up medwatch will be filed as appropriate.

• Brand Name: PFC SIGMARP STB TB IN 2 12.5
• Common Device Name: SIGMA KNEE PRIMARY : KNEE TIBIAL INSERT
• Manufacturer (Section D): DEPUY ORTHOPAEDICS INC US; 700 orthopaedic drive; warsaw IN 46582 0988
• MDR Report Key: 8256656
• Report Number: 1818910-2019-81233
• Device Sequence Number: 19410055
• Product Code: NJL
• UDI-Device Identifier: 10603295241119
• UDI-Public: 10603295241119
• Combination Product (Y/N): N
• Initial Reporter State: OH
• Initial Reporter Country: US
• PMA/510(K) Number: P830055
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Explanted Year: 2018
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 12/21/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Catalogue Number: 962112
• Device Lot Number: 2417446
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/27/2018
• Initial Date Received by Manufacturer: 12/21/2018
• Supplement Date Received by Manufacturer: 01/21/2019
• Initial Report FDA Received Date: 01/17/2019
• Supplement Report FDA Received Date: 01/21/2019
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 58 YR