MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS, INC. 1818910 PFC SIGMA MOD TIB TRAY CEM SZ2; KNEE TIBIAL TRAY

Catalog Number	866022
Medical Device Problem Code	Loss of or Failure to Bond (1068)
Health Effect - Clinical Code	No Information (3190)
Date of Event	09/13/2017
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
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 to address loosening of the tibial component at the cement to implant interface, competitor cement was used.Femoral component was not loose but also revised due to surgeon preference.Patella was not loose.
Additional Manufacturer Narrative
The device associated with this reported event was not received for examination.Depuy considers the investigation closed.Should additional information be received, the information will be reviewed and the investigation will be re-opened as necessary.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

• Brand Name: PFC SIGMA MOD TIB TRAY CEM SZ2
• Common Device Name: KNEE TIBIAL TRAY
• Manufacturer (Section D): DEPUY ORTHOPAEDICS, INC. 1818910; 700 orthopaedic drive; warsaw IN 46582
• MDR Report Key: 6947379
• Report Number: 1818910-2017-26442
• Device Sequence Number: 19055398
• Product Code: JWH
• UDI-Device Identifier: 10603295216773
• UDI-Public: 10603295216773
• Combination Product (Y/N): N
• Initial Reporter State: IA
• Initial Reporter Country: US
• PMA/510(K) Number: K884796
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 1997
• Device Explanted Year: 2017
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Health Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 09/13/2017

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: 866022
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 09/13/2017
• Supplement Date Received by Manufacturer: 10/29/2017
• Initial Report FDA Received Date: 10/13/2017
• Supplement Report FDA Received Date: 11/06/2017
• 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: 74 YR
• Patient Weight: 95