MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US SROM NRHFEM W/PIN SM RT 66X62; LPS AND S-ROM : KNEE FEMORAL

Catalog Number	623411R
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	01/07/2026
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
It was reported that srom nrhfem w/pin sm rt 66x62 and lps univ tib hin ins sm 31mm were involved in a reported event during a knee surgery.The patient underwent revision surgery due to a suspected fracture of the hinge femur implant, specifically at the boss where the hinged femur attaches to the femoral sleeve at the morse taper locking interface.A large portion of the fractured implant remained lodged in the universal femoral sleeve, necessitating removal of both the sleeve and stem.Additionally, a packaging issue was noted with the lps univ tib hin ins sm 31mm implant, as its inner packaging was cracked; the implant was used because no alternative was available, and the previously intended implant was dropped.The srom nrhfem w/pin sm rt 66x62 was implanted, and the lps univ tib hin ins sm 31mm with damaged packaging was also implanted.There were no reported patient consequences or injury related to the packaging event, but the implant fracture required corrective invasive surgery for device revision and replacement.
Additional Manufacturer Narrative
Product complaint # (b)(4).Investigation summary- no device associated with this report was received for examination.The product investigation found no evidence suspecting an error in the manufacturing or material that would be a contributing factor in the reported allegation(s).A records evaluation (mre) was not perform.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- the product investigation found no evidence suspecting an error in the manufacturing or material that would be a contributing factor in the reported allegation(s).A manufacturing records evaluation (mre) was not performed.Added: d10 (concomitant).

• Brand Name: SROM NRHFEM W/PIN SM RT 66X62
• 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: 24146007
• Report Number: 1818910-2026-01333
• Device Sequence Number: 9357303
• Product Code: KRO
• UDI-Device Identifier: 10603295179498
• UDI-Public: (01)10603295179498(17)270630(10)M0377X
• Combination Product (Y/N): N
• Initial Reporter State: MI
• Initial Reporter Country: US
• PMA/510(K) Number: K896048
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2022
• 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

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: 623411R
• Device Lot Number: M0377X
• 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: 01/07/2026
• Supplement Date Received by Manufacturer: 01/28/2026
• Initial Report FDA Received Date: 01/22/2026
• Supplement Report FDA Received Date: 01/29/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• 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: LPS UNIV TIB HIN INS SM 31MM.; LPS UNIV TIB HIN INS SM 31MM.
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 60 YR
• Patient Sex: Male
• Patient Weight: 128 KG