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	Extraskeletal ossification (1428); Unspecified Infection (1930)
Date of Event	05/16/2025
Type of Reportable Event	Serious Injury
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.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
It was reported that patient continues to show signs of infection and was brought to the or for bilateral knee revisions.Components were removed and thorough i&ds were performed in conjunction with placement of resorbable antibiotic beads, and placement of new components.Patient did have bilateral i&ds with poly exchanges on (b)(6) 2025.As such, the inserts listed on this submission were from that date.The right knee showed significant heterotopic ossification around the femoral sleeve, suggesting infection on xray, so surgeon to chose to fashion a static spacer utilizing lps components to treat this side.The left side appeared to be doing better, but since hospital admission earlier this week also begin to swell.When checking fixation of the femoral component, the femoral sleeve was able to be removed without signs of bony ingrowth.Lack of ingrowth approximately seven (7) weeks post implantation suggests this too was infected.Tibial component and stem were left in place on the left side since it was well fixed.No delay nor patient harm was noted.While results are not yet available, surgeon does believe infection was still present at the time of this procedure.This infection was believed to be hematogenous spread, as previously reported, and was not related to a procedure.No allegations were made against any components, as they all performed as expected.Components were exchanged due to persistent infection that has yet to be cleared.This report captures the right knee.The left knee is captured on related complaint (b)(4).The procedure on (b)(6) 2025 is captured on related complaint (b)(4).Doi: (b)(6) 2025.Dor: (b)(6) 2025.Affected side: right 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: m3734c and no non-conformance's / 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: m3734c and no non-conformance's / 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 WARSAW MFG SITE; 700 orthopaedic drive; warsaw IN 46582
• Manufacturer Contact: elba bello ; 700 orthopaedic dr.; warsaw, IN 46581 ; 9083863534
• MDR Report Key: 22159197
• Report Number: 1818910-2025-09228
• Device Sequence Number: 18369324
• Product Code: JDQ
• UDI-Device Identifier: 10603295067788
• UDI-Public: (01)10603295067788(17)330430(10)M3734C
• 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: M3734C
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 05/16/2025
• Supplement Date Received by Manufacturer: 06/17/2025
• Initial Report FDA Received Date: 06/06/2025
• Supplement Report FDA Received Date: 06/18/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 05/22/2023
• 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 CEMENTED STEM 14X130MM.; ATTUNE REV LPS INSRT XXSM 16MM.; ATUNE REV RP TIB BASE SZ 3 CEM.; LPS DISTAL FEM COMP XXSM RT.; LPS FEM TO SLEEVE ADAPTER +5.; UNIVERSAL FEM SLV FUL POR 40MM.; UNIVERSAL STEM 75X20MM FLUTED.
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 75 YR
• Patient Sex: Male
• Patient Weight: 72 KG