MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US UNIVERSAL FEM SLV DIS POR 34MM; UNIVERSAL KNEE STEMS AND SLEEVES : KNEE FEMORAL ACCESSORY

Model Number 1294-53-225

Device Problem Off-Label Use (1494)

Patient Problem Insufficient Information (4580)

Event Date 01/26/2023

Event Type  Injury  

Event Description

Implant rupture at the femoral stem: rupture at the connection between the stem and the sleeve.

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 information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

Manufacturer Narrative

Product complaint # (b)(4).Investigation summary - the device associated with this report was returned to depuy synthes for evaluation.Visual examination of the returned device found solidified cement on the porous coating of the sleeve, confirming off label use.Additional monitoring for any potential safety signals will be conducted through complaint trending and other post-market safety surveillance activities.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.Corrected: h3.

• Brand Name: UNIVERSAL FEM SLV DIS POR 34MM
• Type of Device: UNIVERSAL KNEE STEMS AND SLEEVES : KNEE FEMORAL ACCESSORY
• Manufacturer (Section D): DEPUY ORTHOPAEDICS INC US; 700 orthopaedic drive; warsaw IN 46581 0988
• Manufacturer (Section G): DEPUY ORTHOPAEDICS, INC. 1818910; 700 orthopaedic dr.; warsaw IN 46581 0988
• Manufacturer Contact: kate karberg ; 700 orthpaedic dr.; warsaw, IN 46581 ; 3035526892
• MDR Report Key: 16885805
• MDR Text Key: 314730550
• Report Number: 1818910-2023-09817
• Device Sequence Number: 1
• Product Code: JWH
• UDI-Device Identifier: 10603295026297
• UDI-Public: 10603295026297
• Combination Product (y/n): N
• Reporter Country Code: FR
• PMA/PMN Number: P830055
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 05/08/2023

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
• Device Operator: Health Professional
• Device Model Number: 1294-53-225
• Device Catalogue Number: 129453225
• Device Lot Number: J7851C
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/02/2023
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 04/26/2023
• Initial Date FDA Received: 05/08/2023
• Supplement Dates Manufacturer Received: 05/08/2023
• Supplement Dates FDA Received: 05/08/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/03/2020
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Treatment: LPS DISTAL FEM COMP XXSM LT; P.F.C.* FLUT TIB ROD 75X12MM
• Patient Outcome(s): Required Intervention