MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US SROM NRHFEM W/PIN XSMLFT 66X58; LPS AND S-ROM : KNEE FEMORAL

Catalog Number	623421L
Medical Device Problem Code	Device Dislodged or Dislocated (2923)
Health Effect - Clinical Codes	Foreign Body Reaction (1868); Fluid Discharge (2686); Joint Laxity (4526); Swelling/ Edema (4577); Bone Notching (4890)
Date of Event	11/18/2025
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
Patient had swelling in the knee; much fluid drained from joint upon incision and tissue was black (presumably from metallosis).The hinge prosthesis was largely unsupported by bone and it appears that the hinge femur was moving within the sleeve, creating metal debris and instability.Loosening component at the bone to implant interface.Doi: (b)(6) 2023.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 search of the depuy synthes(nc) quality system found no nc¿s associated with this product/lot (product code: 623421l, lot - m34f76) combination.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 search of the depuy nonconformance (nc) quality system found no nc¿s associated with this product<623421l>/lot combination.H11 additional narrative: added: h6 health effect clinical code.
Event or Problem Description
Additional information was received: a.Was the s-rom femur component cemented? - there was significant bone loss so it appears the srom femur was not able to be cemented.B.Was the sleeve implant well-fixed? - the sleeve was well fixed.C.Was the femur to sleeve morse taper connection solid, or had it come loose/lost its morse taper fixation? d.What is the exact allegation against attune rev lps insrt xsm 20mm? - it seemed all the stress placed on the taper had caused the femur to loosen from the sleeve.E.Please provide the lot number and product code for unk knee femoral sleeve.- no allegation regarding the insert, but it was removed and replaced.
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.H11 additional narrative: added: b5, d10, h6 (health - effect code).If information is obtained that was not available for the initial report, a follow-up report will be filed as appropriate.

• Brand Name: SROM NRHFEM W/PIN XSMLFT 66X58
• Common Device Name: LPS AND S-ROM : KNEE FEMORAL
• 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: 23749393
• Report Number: 1818910-2025-21421
• Device Sequence Number: 5892649
• Product Code: JWH
• UDI-Device Identifier: 10603295179504
• UDI-Public: (01)10603295179504(17)280331(10)M34F76
• Combination Product (Y/N): N
• Initial Reporter State: IL
• Initial Reporter Country: US
• PMA/510(K) Number: K905810
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2023
• 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,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?: Yes
• Operator of Device: Health Professional
• Device Catalogue Number: 623421L
• Device Lot Number: M34F76
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 11/18/2025
• Supplement Date Received by Manufacturer: 12/09/2025; 12/18/2025
• Initial Report FDA Received Date: 12/08/2025
• Supplement Report FDA Received Date: 12/15/2025; 12/19/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 04/21/2023
• 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 REV LPS INSRT XSM 20MM.; SROM NRHFEM W/PIN XSMLFT 66X58.
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 68 YR
• Patient Sex: Male