MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US SIG FEM ADAP +2/-2 OFFSET BOLT; SIGMA REVISION IMPLANT : KNEE FEMORAL ACCESSORY

Catalog Number	960784
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	02/06/2024
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.
Event or Problem Description
Patient was revised due to loosening of the femoral at the bone to cement interface.Cement manufacturer was unknown.It was also reported that the offset femoral adapter bolt broke off inside 5 degree femoral adapter, causing the size 4 tc3 femur to become loose.There was surgical delay of 2.5 hours.Doi: (b)(6) 2015.Dor: (b)(6) 2024.Affected side: left knee.
Additional Manufacturer Narrative
Product complaint # (b)(4).Investigation summary : according to the information received, "patient was revised due to loosening of the femoral at the bone to cement interface.Cement manufacturer was unknown.It was also reported that the offset femoral adapter bolt broke off inside 5 degree femoral adapter, causing the size 4 tc3 femur to become loose.There was surgical delay of 2.5 hours.Doi: october 27,2015 / dor: february 6,2024 / affected side: left knee.The product was not returned to depuy synthes, however photos were provided for review.Review of the radiological images and photograph revealed that the threaded portion of the sig fem adap +2/-2 offset bolt has broken off.The broken fragment nor the fracture surface can be observed in the evidence provided.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 manufacturing record evaluation was performed for the finished device [960784 / 702077] number, and no non-conformances / manufacturing irregularities related to the malfunction were identified during manufacturing.The overall complaint was confirmed as the observed condition of the sig fem adap +2/-2 offset 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 [960784 / 702077] number, and no non-conformances / manufacturing irregularities related to the malfunction were identified during manufacturing.
Event or Problem Description
Additional information was received: -yes the bolt was broken into two pieces.

• Brand Name: SIG FEM ADAP +2/-2 OFFSET 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: 18721062
• Report Number: 1818910-2024-03522
• Device Sequence Number: 5586873
• Product Code: JWH
• UDI-Device Identifier: 10603295233947
• UDI-Public: 10603295233947
• Combination Product (Y/N): N
• Initial Reporter State: LA
• Initial Reporter Country: US
• PMA/510(K) Number: K060515
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2015
• Device Explanted Year: 2024
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 02/16/2024

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: 09/30/2025
• Device Catalogue Number: 960784
• Device Lot Number: 702077
• 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: 02/06/2024
• Supplement Date Received by Manufacturer: 04/05/2024
• Initial Report FDA Received Date: 02/16/2024
• Supplement Report FDA Received Date: 04/05/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 10/13/2015
• 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
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 74 YR
• Patient Sex: Male