MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US PFC*MOD PL TB WDG STP-10MM SZ3; SIGMA REVISION IMPLANT : KNEE TIBIAL TRAY ACCESSORY

Model Number	86-0180
Medical Device Problem Code	Loss of or Failure to Bond (1068)
Health Effect - Clinical Codes	Pain (1994); Loss of Range of Motion (2032); Scarring (2061); Discomfort (2330); Fibrosis (3167); No Code Available (3191)
Date of Event	12/05/2018
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
On (b)(6) 2018, the patient underwent a third right knee revision due to pain, arthrofibrosis, discomfort, decreased range of motion, scarring, and tibial loosening at the cement to implant interface.The surgeon noted a tibial stress fracture while removing the tibial tray.The fracture was corrected with a screw and cement.Two depuy cement were used during the first revision on (b)(6) 2016.Doi: (b)(6) 2016 (2 depuy cements); (b)(6) 2018; 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.A worldwide complaint database search found no other related reported incidents against the provided product code/lot number combination since release for distribution.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.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

• Common Device Name: SIGMA REVISION IMPLANT : KNEE TIBIAL TRAY ACCESSORY
• Manufacturer (Section D): DEPUY ORTHOPAEDICS INC US; 700 orthopaedic drive; warsaw IN 46581 0988
• MDR Report Key: 9036409
• Report Number: 1818910-2019-104498
• Device Sequence Number: 2192367
• Product Code: JWH
• UDI-Device Identifier: 10603295215578
• UDI-Public: 10603295215578
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: K923807
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2018
• Device Explanted Year: 2018
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 08/23/2019

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 Model Number: 86-0180
• Device Catalogue Number: 860180
• Device Lot Number: 570439
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 08/23/2019
• Supplement Date Received by Manufacturer: 02/12/2020
• Initial Report FDA Received Date: 09/13/2019
• Supplement Report FDA Received Date: 02/18/2020
• 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: 51 YR