MAUDE Adverse Event Report: DEPUY IRELAND 961610 SIGMA STAB XLK INS 4 10MM; SIGMA KNEE PRIMARY : KNEE TIBIAL INSERT

Catalog Number	158124110
Medical Device Problem Code	Insufficient Device Problem Information (3190)
Health Effect - Clinical Codes	Unspecified Infection (1930); Pain (1994)
Date of Event	03/01/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
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
The patient was revised to address pain.The patient was tested for infection.The results were positive.Implants removed and revision implants were implanted.Doi: unk; dor: (b)(6) 2018; right knee.
Additional Manufacturer Narrative
(b)(4).Investigation summary no device associated with this report was received for examination 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: SIGMA STAB XLK INS 4 10MM
• Common Device Name: SIGMA KNEE PRIMARY : KNEE TIBIAL INSERT
• Manufacturer (Section D): DEPUY IRELAND 961610 ; 700 orthopaedic drive; warsaw IN 46582 0988
• MDR Report Key: 7365343
• Report Number: 1818910-2018-55972
• Device Sequence Number: 13823644
• Product Code: JWH
• UDI-Device Identifier: 10603295064497
• UDI-Public: 10603295064497
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: K040166
• 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: Health Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 03/01/2018

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: 158124110
• Device Lot Number: 8532297
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 03/01/2018
• Supplement Date Received by Manufacturer: 04/18/2018
• Initial Report FDA Received Date: 03/23/2018
• Supplement Report FDA Received Date: 04/24/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 43 YR
• Patient Weight: 158