MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US PFC*SIGMA/RD/DOME PAT 3PEG,35; SIGMA KNEE PRIMARY : KNEE PATELLA

Model Number	96-0111
Medical Device Problem Codes	Loss of or Failure to Bond (1068); Fracture (1260); Naturally Worn (2988)
Health Effect - Clinical Code	Osteolysis (2377)
Date of Event	08/17/2021
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
Patient was revised to address loosening of the tibial tray, femur and patella components at the cement to implant interface.Depuy cement was used.Osteolysis and poly wear were noted.Doi: (b)(6) 2009, dor: (b)(6) 2021, right knee.
Additional Manufacturer Narrative
Product complaint # (b)(4).This report is being submitted pursuant to the provisions of 21 cfr, part 803.This report may be based on information which has not been investigated or verified prior to the required reporting date.This report does not reflect a conclusion by depuy synthes joint reconstruction, or its employees that the report constitutes an admission that the product, depuy synthes joint reconstruction, or its employees caused or contributed to the potential event described in this report.If information is obtained that was not available for the initial report, a follow-up report will be filed as appropriate.
Event or Problem Description
Additional information received indicated that the poly wear was on the insert.The patella was fractured so wear was difficult to determine.
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 : dhr reviewed: product code 960111, work order (b)(4) was manufactured on 23-sep-2009.(b)(4) parts were manufactured per specification and all raw materials met specification.There was no scrap associated with this lot.There was no material reprocessing reports (mrr) associated with this lot.There were no non-conformances associated with this lot.Due to no similar failures found in the dhr review, the root cause of the complaint cannot be determined.

• Common Device Name: SIGMA KNEE PRIMARY : KNEE PATELLA
• Manufacturer (Section D): DEPUY ORTHOPAEDICS INC US; 700 orthopaedic drive; warsaw IN 46581 0988
• Manufacturer (Section G): DEPUY IRELAND 9616671; loughbeg, ringaskiddy co.; cork ; EI
• Manufacturer Contact: kara ditty-bovard ; 700 orthopaedic dr.; warsaw, IN 46581-0988 ; 6107428552
• MDR Report Key: 12435203
• Report Number: 1818910-2021-19476
• Device Sequence Number: 3515750
• Product Code: NJL
• UDI-Device Identifier: 10603295232667
• UDI-Public: 10603295232667
• Combination Product (Y/N): N
• Initial Reporter State: WI
• Initial Reporter Country: US
• PMA/510(K) Number: P830055
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2009
• Device Explanted Year: 2021
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 08/17/2021

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 Expiration Date: 09/30/2014
• Device Model Number: 96-0111
• Device Catalogue Number: 960111
• Device Lot Number: 3006166
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/17/2021
• Supplement Date Received by Manufacturer: 08/26/2021; 11/23/2021
• Initial Report FDA Received Date: 09/07/2021
• Supplement Report FDA Received Date: 09/15/2021; 11/23/2021
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 09/30/2009
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: MBT CEM KEEL TIB TRAY SZ4; PFC SIGMARP STB TB IN 4 12.5; PFC*SIGMA/RD/DOME PAT 3PEG,35; SIGMA PS CEM FEM SZ4 R; SMARTSET GHV GENTAMICIN 40G
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 76 YR
• Patient Sex: Male