MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US PFC SIG MOD TIB TRAY CEM SZ2.5; SIGMA KNEE PRIMARY : KNEE TIBIAL TRAY

Catalog Number	866029
Medical Device Problem Codes	Loss of or Failure to Bond (1068); Migration (4003)
Health Effect - Clinical Code	Not Applicable (3189)
Date of Event	07/16/2018
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
Patient was revised to address subsidence and loosening of the tibia at the cement to implant interface.Cement used was competitor.Patient had primary left knee done in 2003.Patient had a cr sigma and fb tray, cr insert and patella implanted then on (b)(6) 2018 surgeon determined cr femur well fixed and well positioned.Surgeon removed mbt revision tray and cvdrp implanted.Patella and femur left in place.Doi: 2003, dor: (b)(6) 2018, left knee.
Additional Manufacturer Narrative
Product complaint #: (b)(4).Additional information: "the provided photographs were reviewed.The tibial tray shows signs of yellowing oxidation, delamination and wear on the articulating surfaces, as well as material missing from the posterior condyle locations of the implant.".

• Brand Name: PFC SIG MOD TIB TRAY CEM SZ2.5
• 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: 7766899
• Report Number: 1818910-2018-66163
• Device Sequence Number: 19455184
• Product Code: JWH
• UDI-Device Identifier: 10603295216834
• UDI-Public: 10603295216834
• Combination Product (Y/N): N
• Initial Reporter State: DE
• Initial Reporter Country: US
• PMA/510(K) Number: K884796
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• 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): 07/16/2018

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: 866029
• Device Lot Number: 1089498
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 07/16/2018
• Supplement Date Received by Manufacturer: 11/27/2018
• Initial Report FDA Received Date: 08/09/2018
• Supplement Report FDA Received Date: 12/27/2018
• 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: 67 YR
• Patient Weight: 129