MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US 1818910 SIGMA XLK CVD PLUS INS 5 10MM; SIGMA KNEE PRIMARY : KNEE TIBIAL INSERT

Catalog Number	970471
Medical Device Problem Code	Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	Pain (1994)
Date of Event	06/12/2018
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
It was reported that patient had primary right tkr on (b)(6) 2017.Patient presented to surgeon in office with painful instability.Original knee was cr sigma, 5 fb mod tib tray, cvd + insert 5/10mm and 41 patella.Surgeon upsized poly to a 5/15mm cvd + and closed knee following good rom.Doi: (b)(6) 2017; dor: (b)(6) 2018; right knee.
Additional Manufacturer Narrative
Product complaint # :(b)(4).Investigation summary :no device associated with this report was received for examination.If information is obtained that was not available for the initial medwatch , a follow-up medwatch, a follow-up medwatch will be filed as appropriate.

• Brand Name: SIGMA XLK CVD PLUS INS 5 10MM
• Common Device Name: SIGMA KNEE PRIMARY : KNEE TIBIAL INSERT
• Manufacturer (Section D): DEPUY ORTHOPAEDICS INC US 1818910; 700 orthopaedic drive; warsaw IN 46582 0988
• MDR Report Key: 7666107
• Report Number: 1818910-2018-63879
• Device Sequence Number: 11031938
• Product Code: JWH
• UDI-Device Identifier: 10603295250678
• UDI-Public: 10603295250678
• Combination Product (Y/N): N
• Initial Reporter State: DE
• Initial Reporter Country: US
• PMA/510(K) Number: K040166
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2017
• 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): 06/12/2018

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: 970471
• Device Lot Number: 311008
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 06/12/2018
• Supplement Date Received by Manufacturer: 07/27/2018
• Initial Report FDA Received Date: 07/06/2018
• Supplement Report FDA Received Date: 08/02/2018
• 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: 73 YR
• Patient Weight: 98