MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US PFC*SIGMA C/R NPOR FEM RT SZ 3; SIGMA KNEE PRIMARY : KNEE FEMORAL

Model Number	96-0013
Medical Device Problem Codes	Loss of or Failure to Bond (1068); Use of Device Problem (1670); Adverse Event Without Identified Device or Use Problem (2993); Migration (4003)
Health Effect - Clinical Codes	Foreign Body Reaction (1868); Pain (1994); Loss of Range of Motion (2032); Synovitis (2094); Osteolysis (2377); Joint Laxity (4526); Swelling/ Edema (4577)
Date of Event	09/09/2022
Type of Reportable Event	Serious Injury
Event or Problem Description
Clinical notification received for revision due to instability.Date of implant: (b)(6) 2007; date of revision: (b)(6) 2022; (right knee).Treatment: revision; femoral and tibial components were removed.
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.
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: 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
Office note (b)(6) 2022: patient is having pain and feelings of instability in her right knee which feels like her ¿leg is shifting on her when she walks.¿ she has difficulty with activities of daily living.She has moderate effusion and flexion only to 60-70 degrees with significant varus laxity.Radiographs show knee is in more varus alignment when compared to previous radiographs with some collapse.Patella shows some lytic dysvascular changes.(b)(6) 2022: revision performed on revision components in the right knee.Please note, the records indicate this patient underwent a revision of revision components.There is no information provided that indicates the manufacturer of the primary components prior to the first revision.Intraoperative findings state that the femoral adaptor had fractured.There was massive distal femoral osteolysis and massive proximal tibial lysis requiring significant bone grafting.There was fairly significant synovitis secondary to metallosis.The femoral component was rotating and was loose-no interface provided.It could be pushed into varus and valgus stress but could not be disimpacted from the sleeve.The femoral adaptor was broken but still had the threads engaged in the metaphyseal sleeve that could not be disimpacted.Ultimately the surgeon was able to disrupt the taper and remove the femoral component.He chose to leave the metaphyseal sleeve and placed a hinged noiles distal femoral replacement.Patella was worn and removed with the surgeon choosing not to resurface due to lack of bone.
Additional Manufacturer Narrative
Product complaint # (b)(4).Investigation summary the device associated with this complaint was not returned.Photo evidence and x-rays provided were reviewed and found no implant issue.The reported conditions were not confirmed.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 a search of the depuy nonconformance (nc) quality system found no nc¿s associated with this product code 960013/lot code 2365525 combination.Based on the inability to find any nc¿s against the provided product code 960013/lot code 2365525 combination, it is reasonable to conclude that there are no anomalies with regard to manufacturing or inspection contained in the device history records that would contribute to the reported event.

• 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 orthpaedic dr.; warsaw, IN 46581 ; 3035526892
• MDR Report Key: 15500601
• Report Number: 1818910-2022-18926
• Device Sequence Number: 1791524
• Product Code: JWH
• UDI-Device Identifier: 10603295232025
• UDI-Public: 10603295232025
• Combination Product (Y/N): N
• Initial Reporter State: CO
• Initial Reporter Country: US
• PMA/510(K) Number: K943462
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2007
• 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
• Report Date (Section B): 09/28/2022

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?: Yes
• Operator of Device: Health Professional
• Device Model Number: 96-0013
• Device Catalogue Number: 960013
• Device Lot Number: 2365525
• 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: 09/13/2022
• Supplement Date Received by Manufacturer: 09/21/2022; 11/09/2022
• Initial Report FDA Received Date: 09/28/2022
• Supplement Report FDA Received Date: 10/12/2022; 11/10/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 04/13/2007
• 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 SZ3; PFC SIGMARP CV TB/IN S3 12.5; PFC SIGMARP CV TB/IN S3 12.5; PFC*SIGMA/OV/DOME PAT 3PEG,38; UNK KNEE FEMORAL ADAPTOR LPS
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 71 YR
• Patient Sex: Female
• Patient Weight: 82 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White