MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS, INC. 1818910 PFC SIGMA PRIMARY POR TIB S4; SIGMA KNEE PRIMARY : KNEE TIBIAL TRAY

Catalog Number	967508
Medical Device Problem Code	Loss of or Failure to Bond (1068)
Health Effect - Clinical Codes	Pain (1994); Inadequate Osseointegration (2646)
Date of Event	02/07/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Product complaint # (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 to address knee pain in the total knee.It was stated that, there was no patella in the patient from the first surgery.Bone scan was hot around the tibia.It was decided by the doctor that the tibia was loose at the bone to implant interface.Pressfit sigma fb tibia was pulled out and a sigma fixed bearing cemented tibia with a stem replaced the pressfit one.The patella was resurfaced at this time as well.Doi: (b)(6) 2016; 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.Depuy synthes considers the investigation closed at this time.Should additional information be received, the information will be reviewed and the investigation may 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 PRIMARY POR TIB S4
• Common Device Name: SIGMA KNEE PRIMARY : KNEE TIBIAL TRAY
• Manufacturer (Section D): DEPUY ORTHOPAEDICS, INC. 1818910; 700 orthopaedic drive; warsaw IN 46582 0988
• MDR Report Key: 7298812
• Report Number: 1818910-2018-54130
• Device Sequence Number: 16600959
• Product Code: JWH
• UDI-Device Identifier: 10603295250029
• UDI-Public: 10603295250029
• Combination Product (Y/N): N
• Initial Reporter State: CO
• Initial Reporter Country: US
• PMA/510(K) Number: K991106
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2016
• Device Explanted Year: 2018
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Health Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 02/07/2018

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 Expiration Date: 11/30/2025
• Device Catalogue Number: 967508
• Device Lot Number: 715048
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 02/07/2018
• Supplement Date Received by Manufacturer: 11/13/2018
• Initial Report FDA Received Date: 02/27/2018
• Supplement Report FDA Received Date: 11/13/2018
• 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: 74 YR
• Patient Weight: 97