MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS, INC. 1818910 PFC KEEL TIB TRAY CEM SZ2.5; SIGMA KNEE PRIMARY : KNEE TIBIAL TRAY

Catalog Number	864177
Medical Device Problem Code	Loss of or Failure to Bond (1068)
Health Effect - Clinical Codes	Osteolysis (2377); No Code Available (3191)
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.Concomitant medical products: pfc keel tib tray cem sz2.5 knee tibial tray component; pfc*sigma c/s npor fem lt sz 2 knee femur component; unknown knee tibial insert component; unknown knee patella component; unknown bone cement.(b)(4).
Event or Problem Description
The primary surgery was performed 18 years ago (date of primary surgery was unknown).It was reported that the revision surgery was scheduled to be performed by replacing implants (p/ns and lot numbers were unknown) from the patient¿s knee joint due to loosening on (b)(6) 2018.
Additional Manufacturer Narrative
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 will be re-opened as necessary.If information is obtained that was not available for the initial medwatch , a follow-up medwatch, a follow-up medwatch will be filed as appropriate. .

• Brand Name: PFC KEEL TIB TRAY CEM SZ2.5
• 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: 7955954
• Report Number: 1818910-2018-72143
• Device Sequence Number: 857098
• Product Code: JWH
• UDI-Device Identifier: 10603295216391
• UDI-Public: 10603295216391
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K961685
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Explanted Year: 2018
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 09/18/2018

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: 864177
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 09/18/2018
• Supplement Date Received by Manufacturer: 10/24/2018
• Initial Report FDA Received Date: 10/11/2018
• Supplement Report FDA Received Date: 10/24/2018
• 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: 83 YR