MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US UNKNOWN KNEE TIBIAL SLEEVE; JRN : KNEE TIBIAL TRAY ACCESSORY

Catalog Number UNK KNEE TIBIAL SLEEVE

Device Problem Corroded (1131)

Patient Problems Pain (1994); Loss of Range of Motion (2032)

Event Date 05/30/2023

Event Type  Injury  

Manufacturer Narrative

Product complaint # (b)(4).D4-the device catalog number is unknown; therefore, udi is unavailable.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.

Event Description

Article entitled ¿metallosis and corrosion associated with revision total knee arthroplasties with metaphyseal sleeves¿ written by joshua p.Rainey, md, jeremy m.Gililland, md, christopher l.Peters, md, michael j.Archibeck, md, lucas a.Anderson, md, and christopher e.Pelt, md published in arthroplasty on may 30, 2023 was reviewed.The aims of this study were to compare implant survivorship, perioperative factors, and clinical outcomes of dfr vs.Orif for comminuted distal femur fractures.Case 2 ¿ 64-year-old female patient implanted with bilateral sigma tc3 knees.At 1 year she began to experience pain in the right knee and then in the left knee.She experienced decreased rom.Both knees were revised.Right knee the femoral condylar segment was debonded from the surface cement mantle, though the femoral sleeve was well-fixed.The femoral offset adapter and locking bolt were intact, without fracture or loosening.Corrosion was noted at the femoral trunnion to sleeve bore interface.There was abundant scar and fibrotic tissue throughout the knee.Left knee revision - intraoperatively, there was similar abundant fibrotic tissue and evidence of corrosion debris, with significant corrosion at the tibial tray and sleeve interface.Interestingly, in the left knee, we found the proximal tibial tray to be loose with a well-fixed tibial sleeve.The femoral offset adapter and locking bolt were intact, without fracture or loosening.

Manufacturer Narrative

Product complaint # (b)(4).Investigation summary: no device associated with this report was received for examination.This complaint was opened to document complaints derived through a journal article review.Follow-ups were done to try and obtain additional information from the author of the journal article.No further information was received.Device history lot : a manufacturing record evaluation (mre), was not possible because the required lot code was not provided.

• Brand Name: UNKNOWN KNEE TIBIAL SLEEVE
• Type of Device: JRN : KNEE TIBIAL TRAY 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: 17404788
• MDR Text Key: 319922402
• Report Number: 1818910-2023-15332
• Device Sequence Number: 1
• Product Code: NJL
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Literature,Health Professional
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 07/27/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/27/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: UNK KNEE TIBIAL SLEEVE
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 07/31/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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
• Patient Outcome(s): Required Intervention