MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US PFC KEEL TIB TRAY CEM SZ5; SIGMA KNEE PRIMARY : KNEE TIBIAL TRAY

Catalog Number	864183
Medical Device Problem Codes	Loss of or Failure to Bond (1068); Loosening of Implant Not Related to Bone-Ingrowth (4002)
Health Effect - Clinical Codes	Pain (1994); Not Applicable (3189); No Code Available (3191)
Date of Event	10/25/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Product complaint (b)(4).(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
Revision knee surgery required for painful total knee prosthesis.Surgeon was going to perform a patella resurfacing as primary plan, however a large femoral cyst was detected as well as a potentially loose tibial tray, so an entire knee revision was performed.Patient status/ outcome / consequences: yes.
Additional Manufacturer Narrative
Depuy synthes is submitting this report pursuant to the provision of 21 cfr, part 803.The report may be based on the 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.H10 additional narrative: corrected: h6 (closure codes and device codes).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.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

• Brand Name: PFC KEEL TIB TRAY CEM SZ5
• Common Device Name: SIGMA KNEE PRIMARY : KNEE TIBIAL TRAY
• Manufacturer (Section D): DEPUY ORTHOPAEDICS INC US; 700 orthopaedic drive; warsaw IN 46581 0988
• MDR Report Key: 9356058
• Report Number: 1818910-2019-117437
• Device Sequence Number: 469757
• Product Code: JWH
• UDI-Device Identifier: 10603295216452
• UDI-Public: 10603295216452
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• PMA/510(K) Number: K830927
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2015
• Device Explanted Year: 2019
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 10/25/2019

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 Catalogue Number: 864183
• Device Lot Number: D14101165
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 10/25/2019
• Supplement Date Received by Manufacturer: 01/13/2020
• Initial Report FDA Received Date: 11/21/2019
• Supplement Report FDA Received Date: 01/17/2020
• 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 GVF INS 5 8MM
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 61 YR