MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US CONTROL CABLE W/CABLE SLEEVE; HIP MISCELLANEOUS : CABLE/WIRE

Catalog Number	173928000
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Unspecified Infection (1930); Joint Laxity (4526)
Date of Event	04/10/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
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 patient presented with poor patellar tracking and was scheduled for surgery to address.After exposure, surgeon noted the femoral component appeared to be internally rotated.While extracting the femoral component he noticed that the femoral sleeve also moved indicating that it had not yet ingrown.This led the surgeon to believe that the patient could still be infected as he was treated at the previous surgery with a one stage revision for infection.Frozen section was sent to pathology and showed 5 white cells/ high powered field.This result was more indicative of a loose component than infection but surgeon felt compelled to proceed as if infected and also sent cultures.Femoral components were removed and a thorough debridement and irrigation was performed.Femur was then prepared for new components and placement of resorbable antibiotic beads.No delay was encountered and no patient harm noted.Patellar tracking and motion were found to be improved with new components in place.There was loosening reported at non-cemented interface at femoral sleeve.Doi: (b)(6) 2025.Dor: (b)(6) 2025; affected side: left knee.
Additional Manufacturer Narrative
Product complaint # (b)(4).Investigation summary no device associated with this report was received for examination.A manufacturing record evaluation (nc search) was performed for the finished device product code:173928000, lot:m7078j and no non-conformances / manufacturing irregularities were identified.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 a manufacturing record evaluation (nc search) was performed for the finished device product code:173928000, lot:m7078j and no non-conformances / manufacturing irregularities were identified.H11 additional narrative: added: d10 (concomitant).

• Brand Name: CONTROL CABLE W/CABLE SLEEVE
• Common Device Name: HIP MISCELLANEOUS : CABLE/WIRE
• Manufacturer (Section D): DEPUY ORTHOPAEDICS INC US; 700 orthopaedic drive; warsaw IN 46581 0988
• Manufacturer (Section G): JTE RAYNHAM MFG SITE; 325 paramount drive; raynham MA 02767
• Manufacturer Contact: elba bello ; 700 orthopaedic dr.; warsaw, IN 46581 ; 9083863534
• MDR Report Key: 21952548
• Report Number: 1818910-2025-06938
• Device Sequence Number: 8382472
• Product Code: JDQ
• UDI-Device Identifier: 10603295067788
• UDI-Public: (01)10603295067788(17)20340630(10)M7078J
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: K934557
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2025
• Device Explanted Year: 2025
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• 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: 173928000
• Device Lot Number: M7078J
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 04/10/2025
• Supplement Date Received by Manufacturer: 05/02/2025
• Initial Report FDA Received Date: 05/02/2025
• Supplement Report FDA Received Date: 05/05/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 07/29/2024
• 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: ATTUNE REV LPS INSRT XXSM 12MM.; LPS DISTAL FEM COMP XXSM LT.; LPS FEM TO SLEEVE ADAPTER +5.; UNIVERSAL FEM SLV FUL POR 46MM.; UNIVERSAL STEM 75X18MM FLUTED.
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Male