MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US SIGMA FEM ADAPTER 5 DEGREE; SIGMA REVISION IMPLANT : KNEE FEMORAL ACCESSORY

Catalog Number	960781
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Pain (1994); Joint Laxity (4526)
Date of Event	12/19/2022
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Product complaint # (b)(4).This report is being submitted pursuant to the provisions of 21 cfr, part 803 (and/or part 4, as applicable).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, or its employees that the report constitutes an admission that the product, depuy synthes, 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.H11 additional narrative: e3: reporter is a legal attorney.
Event or Problem Description
It was reported that on (b)(6) 2018, patient's left knee was revised to address instability.Intraoperatively, it was identified that the tibial base plate was loose (interface not provided) and had subsided.It was also noted that the well-fixed femur was malpositioned/internally rotated and was explanted along with the tibial tray and insert.The patella component was well-fixed and was retained.Revision tibial tray and revision femur, with sleeve and stem for both side constructs were implanted, there were no complications reported.No product information was provided in the records for revised primary implants or retained patella.The records did provide a partial record of the revision implants placed during (b)(6) 2018 revision--these appear to be only for the femur side of the knee (depuy femur, augments, sleeve, and stem, as well as depuy cement).On (b)(6) 2022, patient's left knee was revised again to address severe pain and gross instability.Intraoperatively, the well-fixed femur components were explanted from the femoral sleeve and stem, which were well-fixed and retained.An s-rom noiles hinged femur with 2 femoral augments was implanted along with 12mm thick hinged insert.All tibial side components were well-fixed and retained, as was the primary patella.There were no reported complications.Doi: (b)(6) 2018 dor: (b)(6) 2022 left knee.
Additional Manufacturer Narrative
Product complaint # (b)(4).Investigation summary : no device associated with this report was received for examination.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 records evaluation (mre) was not perform.As part of our company quality system process, all devices are manufactured, inspected, and distributed to approved specifications.Additional complaint information monitoring for potential safety signals will be conducted through complaint trending as part of the post-market surveillance.If additional information is made available, the investigation will be updated as applicable.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.

• Brand Name: SIGMA FEM ADAPTER 5 DEGREE
• Common Device Name: SIGMA REVISION IMPLANT : KNEE FEMORAL ACCESSORY
• Manufacturer (Section D): DEPUY ORTHOPAEDICS INC US; 700 orthopaedic drive; warsaw IN 46581 0988
• Manufacturer (Section G): JTE WARSAW MFG SITE; 700 orthopaedic drive; warsaw IN 46582
• Manufacturer Contact: kate karberg ; 700 orthpaedic dr.; warsaw, IN 46581 ; 3035526892
• MDR Report Key: 20659138
• Report Number: 1818910-2024-23455
• Device Sequence Number: 8502855
• Product Code: JWH
• UDI-Device Identifier: 10603295233916
• UDI-Public: (01)10603295233916(17)281031(10)J1361M
• Combination Product (Y/N): N
• Initial Reporter State: IL
• Initial Reporter Country: US
• PMA/510(K) Number: K060515
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2018
• Device Explanted Year: 2022
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Other
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup

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 Catalogue Number: 960781
• Device Lot Number: J1361M
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 10/29/2024
• Supplement Date Received by Manufacturer: 11/18/2024
• Initial Report FDA Received Date: 11/11/2024
• Supplement Report FDA Received Date: 11/20/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 11/07/2018
• 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
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 62 YR
• Patient Sex: Female