MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US PFC*SIGMA C/S NPOR FEM RT SZ 5; SIGMA KNEE PRIMARY : KNEE FEMORAL

Model Number	96-0055
Medical Device Problem Code	Loss of or Failure to Bond (1068)
Health Effect - Clinical Codes	Adhesion(s) (1695); Foreign Body Reaction (1868); Pain (1994); No Code Available (3191)
Date of Event	06/24/2013
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
It was reported that revision operative notes (b)(6) 2013 indicate the patient received a right total knee revision due to loose and painful right total knee.Upon entering the joint, metal stained fluid was encountered, synovium showed severe metal staining.Scar tissue was debrided.The tibial insert was noted to have slight wear.The tibial and femoral components were stated to be loose, interface not provided.The patella was also noted to have minimal wear, it was not revised.The surgery was completed without indication of complication by the surgeon.Products implanted at this revision are located on page 13-15.Doi: (b)(6) 2004 dor: (b)(6) 2013 right knee.
Additional Manufacturer Narrative
Product complaint#: (b)(4).This product was reported in error since mrn was found to be a duplicate report of mrn 1818910-2013-212954.Depuy considers the investigation closed at this time.Should any additional information be received to change the outcome of the performed investigation, the complaint will be re-opened.

• Common Device Name: SIGMA KNEE PRIMARY : KNEE FEMORAL
• Manufacturer (Section D): DEPUY ORTHOPAEDICS INC US; 700 orthopaedic drive; warsaw IN 46581 0988
• MDR Report Key: 10542289
• Report Number: 1818910-2020-20277
• Device Sequence Number: 2954530
• Product Code: JWH
• UDI-Device Identifier: 10603295232407
• UDI-Public: 10603295232407
• Combination Product (Y/N): N
• Initial Reporter State: KY
• Initial Reporter Country: US
• PMA/510(K) Number: K950010
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2004
• Device Explanted Year: 2013
• Reporter Type: Manufacturer
• Report Source: health professional,study
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 09/02/2020

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: 96-0055
• Device Catalogue Number: 960055
• Device Lot Number: 3140055K
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 09/02/2020
• Supplement Date Received by Manufacturer: 10/23/2020
• Initial Report FDA Received Date: 09/16/2020
• Supplement Report FDA Received Date: 10/27/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: P.F.C.* TIB STM EXT 4/5/6 30MM.; PFC SIGMA FEM POST AUG SZ5 4MM.; PFC SIGMA FEM POST AUG SZ5 4MM.; PFC SIGMA MOD TIB TRAY CEM SZ4.; PFC SIGMA STAB INS SZ4 12.5MM.; PFC*SIGMA C/S NPOR FEM RT SZ 5.; PFC*SIGMA/OV/DOME PAT 3PEG,41.; PFCSIGMA FEMCEMSTEM15X90MM7DEG.; RADIOPAQUE BONE CEMENT (STYRKER).; RADIOPAQUE BONE CEMENT (STYRKER).; RADIOPAQUE BONE CEMENT (STYRKER).
• Outcome Attributed to Adverse Event: Required Intervention