MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US SIGMA CRVD XLK INS 2.5 10MM; SIGMA KNEE PRIMARY : KNEE TIBIAL INSERT

Model Number	1581-12-110
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Edema (1820); Unspecified Infection (1930); Pain (1994); No Code Available (3191)
Date of Event	08/19/2020
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
Patient presented tuesday, august 18th in dr.(b)(6) clinic with a painful and effused right knee that the physician suspected was infected.The physician elected to perform a irrigate and debridement procedure of patients right knee and also replace the poly in order to gain easier access to the posterior knee.The physician removed the poly that was well fixed and showed no signs of wear.The remaining index components were well fixed and did not need to be explanted.The physician then irrigated the entire joint space before implanting a knee poly the same size and thickiness of the original that was explanted.The physician did not believe any components did not perform as expected.No instrumentation broke during the surgery and there were not time delays.
Additional Manufacturer Narrative
Product complaint # (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.

• Brand Name: SIGMA CRVD XLK INS 2.5 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: 10489661
• Report Number: 1818910-2020-19437
• Device Sequence Number: 2816647
• Product Code: JWH
• UDI-Device Identifier: 10603295063278
• UDI-Public: 10603295063278
• Combination Product (Y/N): N
• Initial Reporter State: PA
• 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): 08/19/2020

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: 1581-12-110
• Device Catalogue Number: 158112110
• Device Lot Number: 2566171
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 08/19/2020
• Supplement Date Received by Manufacturer: 10/04/2020
• Initial Report FDA Received Date: 09/03/2020
• Supplement Report FDA Received Date: 10/06/2020
• 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 CRVD XLK INS 2.5 10MM; SIGMA CRVD XLK INS 2.5 10MM
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 71 YR