MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US PFC*SIGMA C/S NPOR FEM LT SZ 6; SIGMA KNEE PRIMARY : KNEE FEMORAL

Model Number	96-0046
Medical Device Problem Codes	Loss of or Failure to Bond (1068); Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Muscular Rigidity (1968); Pain (1994); Discomfort (2330); Osteolysis (2377); Swelling/ Edema (4577)
Date of Event	03/30/2022
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
Clinical notification received for revision due to pain and stiffness.Date of implant: (b)(6) 2004, date of revision: (b)(6) 2022, (left knee).Revision of the insert, tibial and femoral components.Patella not revised.
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.H10 additional narrative: added: b5 and h6 (patient).If information is obtained that was not available for the initial report, a follow-up report will be filed as appropriate.Corrected: h6 (device).
Event or Problem Description
(b)(6) 2004: patient had a left knee placed due to osteoarthritis.Depuy sigma implants were placed with an unknown cement mfg.No intra-operative complications were noted.(b)(6) 2021: doctor's progress note indicates the patient is experiencing pain and discomfort medially and with patellafemoral articulation.Swelling and small effusion were also noted.No instability were noted.Radiology notes from (b)(6) 2021: wear on both knees.Left knee has osteolysis anterior and posterior portion of the femur and portions around the posterior tibial tray.The right knees shows some medial polyethylene wear, but no significant osteolysis.(b)(6) 2022: patient underwent a left knee revision for failure of fixation.Attune revision implants were placed.Intra-op findings included gross loosening of the femoral component and significant osteolysis of the proximal tibia.Revised tibial insert didn't show significant wear.Femoral component had fibrous fixation, but there was no indication of the loosening interface.Attune revision implants were placed.Cement mfg is unknown.At this time the manufacturer of the right knee is unknown.Additional follow up is be conducted to determine if the mfg.
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 FEMORAL
• 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: kate karberg ; 700 orthopaedic dr.; warsaw, IN 46581-0988 ; 3035526892
• MDR Report Key: 14437071
• Report Number: 1818910-2022-09142
• Device Sequence Number: 12038722
• Product Code: JWH
• UDI-Device Identifier: 10603295232261
• UDI-Public: 10603295232261
• Combination Product (Y/N): N
• Initial Reporter State: WA
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2004
• Device Explanted Year: 2022
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Study,Health Professional
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup,Followup
• Report Date (Section B): 05/18/2022

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 Model Number: 96-0046
• Device Catalogue Number: 960046
• Device Lot Number: 4530046A
• 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: 05/03/2022
• Supplement Date Received by Manufacturer: 05/20/2022; 06/01/2022; 06/10/2022
• Initial Report FDA Received Date: 05/19/2022
• Supplement Report FDA Received Date: 05/31/2022; 06/01/2022; 06/17/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 11/18/2003
• 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: PFC SIGMA MOD TIB TRAY CEM SZ5; PFC SIGMA STAB INS SZ5 8MM; PFC*SIGMA/OV/DOME PAT 3PEG,41; UNKNOWN KNEE PATELLA
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 87 YR
• Patient Sex: Male
• Patient Weight: 109 KG