MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US PFC*SIGMA A/P CVD TB 8MM,SZ 4; SIGMA KNEE PRIMARY : KNEE TIBIAL INSERT

Model Number	96-0650
Medical Device Problem Codes	Unintended Movement (3026); Migration (4003)
Health Effect - Clinical Code	No Code Available (3191)
Date of Event	02/03/2020
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 due to collapsed tibial tray.Doi: (b)(6) 2019; dor: (b)(6) 2020; left knee.
Additional Manufacturer Narrative
Product complaint # (b)(4).Udi: (b)(4).
Event or Problem Description
The product that was taken out was a sigma tibial component all poly curved (960650).The lot number for that item is d16073571.The all poly curved tray acts as an insert and tray as they are combined, so the answer is that is both the tray and insert.
Additional Manufacturer Narrative
Depuy synthes is submitting this report pursuant to the provisions of 21 cfr, part 803.This report may be based on information which depuy synthes has not been able to investigate or verify prior to the required reporting date.This report does not reflect a conclusion by fda, depuy synthes or its employees that the report constitutes an admission that the device, depuy synthes, or its employees caused or contributed to the potential event described in this report.Product complaint # (b)(4).Investigation summary : no device associated with this report was received for examination.A worldwide complaint database search found no other related reported incidents against the provided product code/lot number combination since release for distribution.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.Device history lot : null device history batch : null device history review : null 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.

• 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: 9722959
• Report Number: 1818910-2020-05225
• Device Sequence Number: 19421421
• Product Code: JWH
• UDI-Device Identifier: 10603295233527
• UDI-Public: 10603295233527
• Combination Product (Y/N): N
• Initial Reporter State: MI
• Initial Reporter Country: US
• PMA/510(K) Number: K943462
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2019
• Device Explanted Year: 2020
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 02/03/2020

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?: Yes
• Operator of Device: Health Professional
• Device Model Number: 96-0650
• Device Catalogue Number: 960650
• Device Lot Number: D16073571
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 02/03/2020
• Supplement Date Received by Manufacturer: 02/19/2020; 03/24/2020
• Initial Report FDA Received Date: 02/18/2020
• Supplement Report FDA Received Date: 02/20/2020; 03/27/2020
• 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: COMPETITOR CONE CEMENT
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 74 YR
• Patient Weight: 87