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

Catalog Number	960783
Medical Device Problem Codes	Fracture (1260); No Apparent Adverse Event (3189)
Health Effect - Clinical Codes	Insufficient Information (4580); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/06/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Product complaint # (b)(4).D4: the device catalog number is unknown; therefore, udi is unavailable.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.
Event or Problem Description
It was reported that the femur stem failed.
Additional Manufacturer Narrative
Product complaint # (b)(4).Investigation summary - stem failure femur.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 sigma fem adapter neutral bolt broken at the threaded portion.Upon investigation, characteristic of a high cycle low stress fatigue kind of fracture was identified on the fracture surface.Fractured fragment was not returned for evaluation.Fracture patterns can be observed on page 1 and 2 of the next attachment (pal ¿ (b)(4) - photos taken by (b)(6) - (b)(6) 2024 (2)).No additional damage was observed on device surface.With the information provided is not possible to determine a potential cause at this moment.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 not performed since it was not applicable to the complaint condition.A functional test 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, 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 j3187a number, and no non-conformances /manufacturing irregularities were identified.Corrected h3.
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.
Event or Problem Description
Additional information received: a.Was there a surgical delay? what is the duration of the delay? no b.Were there any adverse consequence/s that affected the patient because of the reported event? no c.Is/are the product/s available for return? yes or no? yes d.Was there any revision surgery that occurred? if yes, please provide the details.Yes, s-rom hinge knee with sleeve & stem femoral and tibial with sleeve and stem e.What is the affected side involved in this event? left f.Please clarify the correct defective device(s) as the event description indicates stem, but a sleeve was reported.Kindly explain the specific defect of the devices.The thread of the +/- bolt has broken, please see the implants.
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.
Event or Problem Description
Additional information was received: let me just be clear that the main problem in this case is the fractured 0mm screw 960783 (j3187a).The 7deg adapter 960782 is automatically connected to this screw.
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 that 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.H10 additional narrative: added: b5.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
Additional information was received: as i was live accompanying the surgery the surgeon could spot the broken screw inside the knee and pointed it out to me.
Additional Manufacturer Narrative
Product complaint(b)(4) investigation summary : according to the information received, "stem failure femur".¿the product was not returned to depuy synthes, however photos were provided for review.See attachment (re pcf (b)(4) kantonsspital olten).The x-ray investigation revealed a separation between the femoral component and the sigma fem adapter neutral bolt, suggesting a device malfunction.However, it is not possible to fully confirm a fracture of the device with the provided evidence due to the photo quality.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.Since the device was not returned, a dimensional inspection cannot be performed.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, 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 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 j3187a number, and no non-conformances /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): JTE WARSAW MFG SITE; 700 orthopaedic drive; warsaw IN
• Manufacturer Contact: kate karberg ; 700 orthopaedic dr.; warsaw, IN 46581-0988 ; 3035526892
• MDR Report Key: 18705777
• Report Number: 1818910-2024-03257
• Device Sequence Number: 14888241
• Product Code: JWH
• UDI-Device Identifier: 10603295233930
• UDI-Public: 10603295233930
• Combination Product (Y/N): N
• Initial Reporter Country: SZ
• PMA/510(K) Number: K060515
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2019
• Device Explanted Year: 2024
• 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): 02/14/2024
• 2 Devices were Involved in the Event: 1 2

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: 960783
• Device Lot Number: J3187A
• 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: 02/06/2024
• Supplement Date Received by Manufacturer: 03/06/2024; 04/10/2024; 04/29/2024; 05/03/2024; 05/08/2024; 05/31/2024
• Initial Report FDA Received Date: 02/14/2024
• Supplement Report FDA Received Date: 03/21/2024; 04/16/2024; 04/30/2024; 05/06/2024; 05/13/2024; 06/05/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/28/2019
• 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 37MM.; PFC SIGMA FEM POST AUG SZ3 4MM.; PFC*SIGMA DI AUG12MMCO,SZ3LEFT.; PFC*SIGMA TC3 FEM LEFT SZ3.; PFC*SIGMA/OV/DOME PAT 3PEG,38.; SIGMA FEM ADAPTER 7 DEGREE.; TC3 RP TIBIAL INSERT S3,25.0.; UNIVERSAL FEM SLV FUL POR 46MM.; UNIVERSAL FEM SLV FUL POR 46MM.; UNIVERSAL STEM 75X14MM FLUTED.
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 59 YR
• Patient Sex: Female