MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US SIGMA FEM ADAPTER 5 DEGREE; PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED

Catalog Number	960781
Medical Device Problem Code	No Apparent Adverse Event (3189)
Health Effect - Clinical Codes	Foreign Body Reaction (1868); Muscular Rigidity (1968); Pain (1994); Synovitis (2094); Osteolysis (2377); Ambulation or Postural Difficulties (2544); Swelling/ Edema (4577)
Date of Event	01/01/2016
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that the patient states he had knee replacement around 2004, had revision done in 2016 in (b)(6) by surgeon at a hospital.He continued to have issues and in (b)(6) 2023, he went to another surgeon in another hospital who replaced what he considered damaged components.
Additional Manufacturer Narrative
Product complaint # (b)(4).Depuy synthes is submitting this report pursuant to the provisions of 21 cfr, part 803.This report may be based on information which depuy synthes has not been able to investigate or verify prior to the required reporting date.This report does not reflect a conclusion by fda, depuy synthes or its employees that the report constitutes an admission that the device, depuy synthes, or its employees caused or contributed to the potential event described in this report.If the information is unknown, not available or does not apply, the section/field of the form is left blank.H11 additional narrative: d1, d2, d3, d4, g4-510k: this report is for an unk knee femoral adaptor/unknown lot.Part and lot number are unknown.Without the specific part number, the udi number and 510-k number is unknown.Investigation summary patient states he had knee replacement around 2004, had revision done in 2016 in (b)(6) by surgeon at a hospital.He continued to have issues and in (b)(6) 2023 went to another surgeon in another hospital who replaced what he considered damaged components.The product was not returned to j&j medtech orthopaedics; however, photos and a video were provided for review.The photo/video investigation revealed that looseness can be seen in the unknown knee femoral adaptor device, it is reasonable to conclude that a disassociation event occurred between the unknown knee femoral adaptor bolt and the unknown knee femoral adaptor.The device lot number is unknown, therefore a¿device history review could not be performed.If the lot/serial number becomes available, the record will be re-assessed.The mode of failure of the device is multi-factorial and consideration must be given to all other potential influences such as surgical process, patient variables (e.G.Activity level and use), anatomical considerations and patient changes over time.Any conclusions from the investigational input provided have to be placed into context with all other relevant factors.As the device was not returned, an as-received condition could not be assessed, and a dimensional inspection and document/specification review were not completed.The overall complaint was confirmed as the observed condition of the unknown knee femoral adaptor would have contributed to the complained device issue.Based on the investigation findings, it has been determined that no corrective and/or preventative action is proposed.There is no indication that a design or manufacturing issue has caused the complaint condition.As part of j&j medtech orthopaedics quality process, all devices are manufactured, inspected, and released to approved specifications.Additional monitoring for any potential safety signals will be conducted through complaint trending and other post-market safety surveillance activities.Device history lot the device lot number is unknown, therefore a¿device history review could not be performed.If the lot/serial number becomes available, the record will be re-assessed.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 hat 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.H11 additional narrative: added: a1, a2 (dob), a3a (sex), b5, b7, d4 (lot, expiration date), d6b, d10, g4, h4 and h6 (health effect - clinical code) corrected: d1, d2a, d2b, d4 (catalog, udi).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
Medical records received.Doi: (b)(6) 2016: 65-year-old male patient received a right knee revision of unknown implants to treat tibial tray loosening, metallosis, and osteolysis.The implants revised in this procedure are unknown and will not be captured as a complaint.The patient received a tc3 revision knee, depuy resurfaced patella, and depuy cement x 4.The procedure was completed without complications.Dor: (b)(6) 2023: 73- year-old male patient received a right knee revision to treat progressive pain, swelling, walking difficulty, and stiffness.Upon entering the joint, the surgeon debrided metallosis and synovitis.The surgeon determined the cause of the metallosis was the disassociation of the femoral adaptor and adaptor bolt, causing movement at the adaptor and bolt junction.There was no reported product problem with the revised femoral component.The femoral sleeve and stem were well-fixed and retained.The patella was loosened at an unknown interface secondary to patellar osteolysis and revised.There was no reported product problem with the revised tibial insert.The tibial tray, sleeve, and stem were well-fixed and retained.There was some medial tibial osteolysis that was treated with impaction bone grafting.The patient was revised with competitor cement and depuy tc3 implants.The procedure was completed without complications.Doi: (b)(6) 2016.Dor (b)(6) 2023.Right knee.
Additional Manufacturer Narrative
Product complaint # (b)(4).Investigation summary: patient states he had knee replacement around 2004, had revision done in 2016 in california by surgeon at a hospital.He continued to have issues and in (b)(6) 2023 went to another surgeon in another hospital who replaced what he considered damaged components.He has spoken with attorney.Patient status/ outcome / consequences, was other medical intervention (e.G.X-rays, additional procedures, prescriptions, otc, revision) required: unknown.Is the patient part of a clinical study: unknown.(b)(4).Device property of: none.Device in possession of: none.By checking this box i certify that all information that are known/available has been disclosed.If any new information will be made available, the additional information will be submitted through cst.True.The product was not returned to j&j medtech orthopaedics; however, photos and a video were provided for review.See attachment (b)(4) device video ad 31 jul 2024, (b)(4) device photo ad 31 jul 2024 (1), (b)(4) device photo ad 31 jul 2024 (2), (b)(4) external knee revision (2.53 mb).The photo/video investigation revealed that looseness can be seen in the sigma fem adapter 5 degree, it is reasonable to conclude that a disassociation event occurred between the sig fem adap +2/-2 offset bolt and the sigma fem adapter 5 degree.Although disassociation was observed on both devices, they remained attached and assembled.A manufacturing record evaluation was performed for the finished device product code: 960781 lot number: c83056, and no non-conformances or manufacturing irregularities were identified.The mode of failure of the device is multi-factorial and consideration must be given to all other potential influences such as surgical process, patient variables (e.G.Activity level and use), anatomical considerations and patient changes over time.Any conclusions from the investigational input provided have to be placed into context with all other relevant factors.As the device was not returned, an as-received condition could not be assessed, and a dimensional inspection and document/specification review were not completed.The overall complaint was confirmed as the observed condition of the sigma fem adapter 5 degree would have contributed to the complained device issue.Based on the investigation findings, it has been determined that no corrective and/or preventative action is proposed.There is no indication that a design or manufacturing issue has caused the complaint condition.As part of j&j medtech orthopaedics quality process, all devices are manufactured, inspected, and released to approved specifications.Additional monitoring for any potential safety signals will be conducted through complaint trending and other post-market safety surveillance activities.Device history lot: a manufacturing record evaluation was performed for the finished.Device product code: 960781 lot number: c83056, and no non-conformances or manufacturing irregularities were identified.

• Brand Name: SIGMA FEM ADAPTER 5 DEGREE
• Common Device Name: PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED
• 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 orthopaedic dr.; warsaw, IN 46581 ; 3035526892
• MDR Report Key: 21646586
• Report Number: 1818910-2025-04208
• Device Sequence Number: 7614904
• Product Code: JWH
• UDI-Device Identifier: 10603295233916
• UDI-Public: (01)10603295233916(17)260831(10)C83056
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: K060515
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Explanted Year: 2023
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Other,Health Professional,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,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?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 08/31/2026
• Device Catalogue Number: 960781
• Device Lot Number: C83056
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 02/25/2025
• Supplement Date Received by Manufacturer: 04/16/2025; 07/21/2025
• Initial Report FDA Received Date: 03/19/2025
• Supplement Report FDA Received Date: 04/30/2025; 07/22/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 09/20/2016
• 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: Unknown
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: LCS CRUC M/B PAT REPLC GVF LG+.; MBT REVISION CEM TIB TRAY SZ 5.; PFC*SIGMA TC3 FEM RT SZ5.; SIG FEM ADAP +2/-2 OFFSET BOLT.; SMARTSET GHV GENTAMICIN 40G.; SMARTSET GHV GENTAMICIN 40G.; SMARTSET GHV GENTAMICIN 40G.; SMARTSET GHV GENTAMICIN 40G.; TC3 RP TIBIAL INSERT S5,20.0.
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 65 YR
• Patient Sex: Male