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

Model Number	96-0783
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	06/26/2023
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Product complaint # = > pc-(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
Knee replacement tc3 surgery 8 years ago with stem and sleeves both tibia and femur.Adapter and bolt is broken.Femur had no contact.Sleeve very well fixated.Patient status/ outcome / consequences --> yes, patient consequence description/was there a clinical outcome experienced by the patient (infection, inflammation, etc.)?--> extraction of the implants, surgery with spacer and planned for lps revision., was other medical intervention (e.G.X-rays, additional procedures, prescriptions, otc, revision) required: --> unknown, if yes, describe --> extraction of the implants, surgery with spacer and planned for lps revision., is the patient part of a clinical study --> unknown, ip-(b)(4) device property of -->none, device in possession of -->none, ip-(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.
Event or Problem Description
Additional information was received and stated the following: the femur was confirmed to be loose.There was no damage on the sleeve, it was well fixed in the bone.There were no patient adverse consequences reported.Dor: (b)(6) 2023.
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, d6b if information is obtained that was not available for the initial report, a follow-up report 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: added: d9 and d10 if information is obtained that was not available for the initial report, a follow-up report 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.If information is obtained that was not available for the initial report, a follow-up report 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.If information is obtained that was not available for the initial report, a follow-up report will be filed as appropriate.
Additional Manufacturer Narrative
Product complaint (b)(4).Investigation summary : knee replacement tc3 surgery 8 years ago with stem and sleeves both tibia and femur.Adapter and bolt is broken.Femur had no contact.Sleeve very well fixated.The product was returned to depuy synthes for evaluation.The depuy synthes team conducted a visual inspection of the returned device.Visual inspection found the device broken at the start of the threaded part of the shaft, the fractured surface can be seen smooth and polished, suggesting high cycle low stress fatigue fracture.With the information provided is not possible to determine a potential cause at this moment, however in support of the evaluation performed, the observed damage of the sigma fem adapter neutral bolt may have been caused by exposure to irregularities in the weight loading of the device and moments generated.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.A dimensional inspection was unable to be performed due to the post-manufacturing damage.The overall complaint was confirmed as the observed condition of the [sigma fem adapter neutral bolt] would contribute to the complained device issue.  based on the investigation findings, the potential cause cannot be established with the information provided, and 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 reported complaint condition.As part of depuy synthes 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 lot# 659119, and no nonconformances or manufacturing irregularities were identified.

• Brand Name: SIGMA FEM ADAPTER NEUTRAL BOLT
• 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): DEPUY ORTHOPAEDICS, INC. 1818910; 700 orthopaedic dr.; warsaw IN 46581 0988
• Manufacturer Contact: kate karberg ; 700 orthpaedic dr.; warsaw, IN 46581 ; 3035526892
• MDR Report Key: 17313392
• Report Number: 1818910-2023-14076
• Device Sequence Number: 17161263
• Product Code: JWH
• UDI-Device Identifier: 10603295233930
• UDI-Public: 10603295233930
• Combination Product (Y/N): N
• Initial Reporter Country: SW
• PMA/510(K) Number: K060515
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2015
• Device Explanted Year: 2023
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup,Followup,Followup
• Report Date (Section B): 07/12/2023

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: 96-0783
• Device Catalogue Number: 960783
• Device Lot Number: 659119
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/28/2023
• Supplement Date Received by Manufacturer: 07/18/2023; 10/10/2023; 10/18/2023; 11/22/2023; 11/29/2023
• Initial Report FDA Received Date: 07/12/2023
• Supplement Report FDA Received Date: 07/27/2023; 10/11/2023; 11/01/2023; 11/28/2023; 11/29/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/18/2015
• 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 REVISION CEM TIB TRAY SZ 3; MBT REVISION CEM TIB TRAY SZ 3; MBT TRAY SLEEVE POR M/L 45MM; MBT TRAY SLEEVE POR M/L 45MM; S-ROM*SLEEVE PRX ZTT, 20D-SML; S-ROM*SLEEVE PRX ZTT, 20D-SML; SIGMA FEM ADAPTER 5 DEGREE; SIGMA FEM ADAPTER 5 DEGREE; SIGMA FEM ADAPTER NEUTRAL BOLT; TC3 RP TIBIAL INSERT S3,12.5; UNIVERSAL FEM SLV DIS POR 40MM; UNIVERSAL FEM SLV DIS POR 40MM; UNIVERSAL STEM 75X12MM FLUTED; UNIVERSAL STEM 75X12MM FLUTED; UNIVERSAL STEM 75X16MM FLUTED; UNIVERSAL STEM 75X16MM FLUTED; UNK COMPETITOR CEMENT; UNK COMPETITOR CEMENT; UNK KNEE FEMORAL SIGMA; UNK KNEE FEMORAL SIGMA; UNK PATELLA TRIAL; UNKNOWN KNEE FEMORAL STEM; UNKNOWN KNEE FEMORAL STEM
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown