MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US SIGMA STAB XLK INS 2 10MM; SIGMA KNEE PRIMARY : KNEE TIBIAL INSERT

Model Number	1581-21-110
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Unspecified Infection (1930); Discomfort (2330); No Code Available (3191)
Date of Event	05/22/2020
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
The patient was revised to address some discomfort and infection.The surgeon performed irrigation and debridement and replaced the poly.A size 2 10mm stabilized poly was removed.The surgeon trialed the 10mm insert after performing a synovectomy and thoroughly washing out the knee.Surgeon decided a little more tension was desired and trialed a 12.5mm insert.It was found to be satisfactory and the real insert was opened and implanted.Closing process began.Surgeon was unsure of when and where the patient had their initial knee surgery done.Doi: unknown.Dor: (b)(6) 2020; right knee.
Additional Manufacturer Narrative
Product complaint # (b)(4).Investigation summary : no device associated with this report was received for examination.A worldwide lot specific complaint database search, or device history record (dhr) review, was not possible because the required lot number was not provided.Based on previous investigations, this complication of joint replacement is unlikely to have been the result of a device failing to meet required specifications.The information received will be retained for potential series investigations if triggered by trend analysis, post market surveillance, or other events within the quality system.

• Brand Name: SIGMA STAB XLK INS 2 10MM
• Common Device Name: SIGMA KNEE PRIMARY : KNEE TIBIAL INSERT
• Manufacturer (Section D): DEPUY ORTHOPAEDICS INC US; 700 orthopaedic drive; warsaw IN 46581 0988
• MDR Report Key: 10114349
• Report Number: 1818910-2020-13110
• Device Sequence Number: 19294849
• Product Code: JWH
• UDI-Device Identifier: 10603295064015
• UDI-Public: 10603295064015
• Combination Product (Y/N): N
• Initial Reporter State: MI
• Initial Reporter Country: US
• PMA/510(K) Number: K040166
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Explanted Year: 2020
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 05/22/2020

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 Model Number: 1581-21-110
• Device Catalogue Number: 158121110
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 05/22/2020
• Supplement Date Received by Manufacturer: 07/07/2020
• Initial Report FDA Received Date: 06/03/2020
• Supplement Report FDA Received Date: 07/08/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: SIGMA STAB XLK INS 2 10MM; SIGMA STAB XLK INS 2 10MM
• Outcome Attributed to Adverse Event: Required Intervention