MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US PFC*SIGMA/RD/DOME PAT 3PEG,38; SIGMA KNEE PRIMARY : KNEE PATELLA

Model Number	96-0112
Medical Device Problem Code	Naturally Worn (2988)
Health Effect - Clinical Codes	Pain (1994); Synovitis (2094); Ambulation or Postural Difficulties (2544); Joint Laxity (4526)
Date of Event	06/02/2018
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
Clinical adverse event received for poly wear and spin out.Severe posterior tibial insert wear and erosion with erosion and wear of tibial post.Also severe patellar wear with delamination.Event is serious and is considered severe.Event is definitely related to device and definitely not related to procedure.(b)(6) 2021 - the patient received a left total knee revision due to increasing pain, feeling of a ¿locked knee¿ and difficulty ambulating.Pre-revision the knee was demonstrating subluxation ¿ possibly full anterior dislocation of the femur on the tibia.Upon entering the joint, there was clear leakage of lymph fluid.Some metallosis staining of the synovium noted.The patella component was noted to be worn and delaminated.The insert component was worn with erosions as well.The insert and patella components were revised.The surgery was completed without indication of complication by the surgeon.Date of implant: (b)(6) 2003; date of event: (b)(6) 2018; date of revision: (b)(6) 2021 ; (left knee).Treatment: revision of insert and patella.
Additional Manufacturer Narrative
Product complaint # (b)(4).Investigation summary: no device associated with this report was received for examination.The information received will be retained for potential series investigations if triggered by trend analysis, post market surveillance, or other events within the quality system.Depuy considers the investigation closed.Should additional information be received, the information will be reviewed and the investigation will be re-opened as necessary.Device history lot: the product investigation found no evidence suspecting an error in the manufacturing or material that would be a contributing factor in the reported allegation(s).A manufacturing records evaluation (mre) was not performed.

• Common Device Name: SIGMA KNEE PRIMARY : KNEE PATELLA
• Manufacturer (Section D): DEPUY ORTHOPAEDICS INC US; 700 orthopaedic drive; warsaw IN 46581 0988
• MDR Report Key: 12267038
• Report Number: 1818910-2021-16808
• Device Sequence Number: 12073337
• Product Code: JWH
• UDI-Device Identifier: 10603295232681
• UDI-Public: 10603295232681
• Combination Product (Y/N): N
• Initial Reporter State: CT
• Initial Reporter Country: US
• PMA/510(K) Number: P830055
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2003
• Device Explanted Year: 2021
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 07/09/2021

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: 96-0112
• Device Catalogue Number: 960112
• Device Lot Number: 1087461
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 07/09/2021
• Supplement Date Received by Manufacturer: 08/31/2021
• Initial Report FDA Received Date: 08/03/2021
• Supplement Report FDA Received Date: 09/01/2021
• 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: MBT CEM KEEL TIB TRAY SZ3.; PFC SIGMARP STB TB IN 4 10.0.; PFC*SIGMA C/S NPOR FEM LT SZ 4.; PFC*SIGMA/RD/DOME PAT 3PEG,38.; MBT CEM KEEL TIB TRAY SZ3; PFC SIGMARP STB TB IN 4 10.0; PFC*SIGMA C/S NPOR FEM LT SZ 4; PFC*SIGMA/RD/DOME PAT 3PEG,38
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 79 YR
• Patient Weight: 120