MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US SIG TIB CEM STM 13X60 2/2.5/3; UNIVERSAL KNEE STEMS AND SLEEVES : KNEE STEMS

Catalog Number	866402
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	Bone Fracture(s) (1870)
Date of Event	03/20/2025
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.H11 additional narrative: d4: udi: as the lot number for the device involved in the event was not provided, the full udi is currently not available.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 the stem from a previous distal femur replacement broke.Revision dfr was performed.Doi: unknown.Dor: (b)(6) 2025.Affected side: right knee.
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.If information is obtained that was not available for the initial report, a follow-up report will be filed as appropriate.
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: d4 (lot), d9, h4 corrected: d4 primary udi number if information is obtained that was not available for the initial report, a follow-up report will be filed as appropriate.
Additional Manufacturer Narrative
Product complaint # (b)(4).Investigation summary = > it was reported that the stem from a previous distal femur replacement broke.Revision dfr was performed.The product was returned to j&j medtech orthopaedics for evaluation.The complaint unit was forwarded was forwarded to the j&j medtech orthopaedics material science lab in warsaw for further evaluation.Visual analysis of the returned device revealed that the distal portion of the stem was securely retained within the sleeve.Evaluation of the distal fracture surface suggested a posteromedial initiation region with an anterior final failure region.Stereomicroscopic evaluation of the proximal fracture surface revealed ratchet marks near the initiation region, further suggesting multiple posteromedial initiation regions.Scanning electron microscopy (sem) was performed on the proximal fracture surface of the stem and revealed fatigue striations indicative of fatigue crack initiation and propagation.The entire fracture surface not obscured by burnishing exhibited fatigue fracture features.The likely overload shear lip region comprises approximately 15% of the surface.This suggests low stress, high cycle fatigue failure, as higher stresses would yield larger overload regions.All observed fracture features were consistent with low-stress, high cycle fatigue for titanium alloys.No material or manufacturing defects were observed that could have contributed to fracture initiation and/or propagation to failure.A search of the j&j medtech orthopaedics nonconformance (nc) quality system found no nc¿s associated with this product/lot combination.Although a definitive cause for device fracture is not established, 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.The overall complaint was confirmed as the observed condition of the sig tib cem stm 13x60 2/2.5/3 would have contributed to the complained 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 j&j medtech orthopaedics 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 search of the j&j medtech orthopaedics nonconformance (nc) quality system found no nc¿s associated with this product/lot combination.
Event or Problem Description
Additional information received states that the previous femur fracture did not involve depuy synthes hardware.

• Brand Name: SIG TIB CEM STM 13X60 2/2.5/3
• Common Device Name: UNIVERSAL KNEE STEMS AND SLEEVES : KNEE STEMS
• 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: 21880928
• Report Number: 1818910-2025-05741
• Device Sequence Number: 12921935
• Product Code: JWH
• UDI-Device Identifier: 10603295216902
• UDI-Public: (01)10603295216902(17)310831(10)D21082314
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: K882234
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2021
• Device Explanted Year: 2025
• 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,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: 866402
• Device Lot Number: D21082314
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 03/23/2025
• Supplement Date Received by Manufacturer: 04/25/2025; 04/29/2025; 07/22/2025
• Initial Report FDA Received Date: 04/22/2025
• Supplement Report FDA Received Date: 04/28/2025; 05/01/2025; 07/23/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/03/2021
• 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: (B)(6).; LPS DISTAL FEM COMP XXSM RT.; LPS FEM TO SLEEVE ADAPTER +5.; LPS SEGMENTAL COMPONENT 25MM.; LPS UNIV TIB HIN INS XXSM 12MM.; SIG TIB CEM STM 13X60 2/2.5/3.
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 77 YR
• Patient Sex: Female