MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US TAPER CEM STEM 13X90; UNIVERSAL KNEE STEMS AND SLEEVES : KNEE STEMS

Catalog Number	866468
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	05/20/2025
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.H11 additional narrative: d4: udi: the expiration date is currently not available.Therefore, the full udi is currently not available.H3, h6 investigation summary: no device associated with this report was received for examination.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.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.
Event or Problem Description
It was reported that patient's distal femoral replacement was revised because the 13x90 cemented stem broke off at the femoral sleeve junction.There was loosening of femoral sleeve at non-cemented interface due to stem breaking.Unknown cement was used.Affected side: unknown knee.
Additional Manufacturer Narrative
Product complaint#: (b)(4).Investigation summary: no device associated with this report was received for examination.A manufacturing record evaluation was performed for the finished device lot number: d17011114, and no non-conformance's / manufacturing irregularities were identified.After searching "d17011114" in etq, no record is displayed.After searching "stem" in etq and all results have been reviewed, no case even similar to the issue described in this complaint is identified.After searching "d17011114" in sap by zqmr1023, no internal lock record is displayed.Hereby drawing a conclusion that no non-conformance's were identified for this batch of products.1) quantity manufactured: (b)(4) pcs.2) date of manufacture: 23-jan-2017.3) any anomalies or deviations identified in dhr: no non-conformance's were identified.4) expiry date: 31-dec-2026.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 was performed for the finished device lot number: d17011114, and no non-conformance's / manufacturing irregularities were identified.After searching "d17011114" in etq, no record is displayed.After searching "stem" in etq and all results have been reviewed, no case even similar to the issue described in this complaint is identified.After searching "d17011114" in sap by zqmr1023, no internal lock record is displayed.Hereby drawing a conclusion that no non-conformance's were identified for this batch of products.1) quantity manufactured: (b)(4) pcs.2) date of manufacture: 23-jan-2017.3) any anomalies or deviations identified in dhr: no non-conformance's were identified.4) expiry date: 31-dec-2026.Device history review: a manufacturing record evaluation was performed for the finished device, and no non-conformance's / manufacturing irregularities related to the malfunction were identified.H11 additional narrative: added: d10 (concomitant).Corrected: d4 (expiry date, primary udi number).

• Brand Name: TAPER CEM STEM 13X90
• 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): JJMSZ PLANT FOR STK. & N-STK.; no. 299, changyang street; suzhou industrial park; suzhou, jiangsu 21512 6; CH 215126
• Manufacturer Contact: elba bello ; 700 orthopaedic dr.; warsaw, IN 46581 ; 9083863534
• MDR Report Key: 22213985
• Report Number: 1818910-2025-09793
• Device Sequence Number: 15491022
• Product Code: JWH
• UDI-Device Identifier: 10603295217176
• UDI-Public: (01)10603295217176(17)261231(10)D17011114
• Combination Product (Y/N): N
• Initial Reporter State: OH
• Initial Reporter Country: US
• PMA/510(K) Number: K882234
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2024
• 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

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: 866468
• Device Lot Number: D17011114
• 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: 05/20/2025
• Supplement Date Received by Manufacturer: 06/23/2025
• Initial Report FDA Received Date: 06/16/2025
• Supplement Report FDA Received Date: 06/24/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 01/23/2017
• 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: UNIVERSAL FEM SLV FUL POR 34MM.; UNKNOWN BONE CEMENT.
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Male