MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US UNKNOWN KNEE TIBIAL SLEEVE

Catalog Number UNK KNEE TIBIAL SLEEVE

Device Problem Corroded (1131)

Patient Problems Foreign Body Reaction (1868); Pain (1994)

Event Date 05/30/2023

Event Type  Injury  

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 4 ¿ 66-year-old male implanted with sigma tc3 in his right knee.He presented to our clinic 4 years later with recurrent pain in his r tka and a large soft tissue mass at the medial aspect of his knee.A punch biopsy was performed at an outside facility, which revealed benign fibrous material, and he continued to drain from this site for 2 weeks.Given his history of draining sinus over his medial knee mass, which was believed to communicate to the hardware via the tibial erosion, the decision was made to perform a 2-stage revision tka.At his stage one revision tka, the knee did not appear infected, and all cultures were ultimately negative.The mass was decompressed, and an articulating antibiotic spacer was placed.Corrosion debris was seen at the end of the tibial female bore (sleeve), near the site of the tibial bone erosion and adjacent mass that was consistent with a pseudotumor-like appearance.The femoral component also demonstrated corrosion at the femoral trunnion and sleeve the femoral offset adapter and locking bolt were intact, without fracture or loosening.Three months later, he was taken for stage 2 reimplant.

Manufacturer Narrative

Product complaint # :(b)(4).D4: the device catalog number is unknown; therefore, udi is unavailable.The size of the article is too large to attach/submit with the 3500a submission.The citation of the article has been provided below: ¿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.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: 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: UNKNOWN KNEE TIBIAL SLEEVE
• 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 orthopaedic dr.; warsaw, IN 46581-0988 ; 3035526892
• MDR Report Key: 17406751
• MDR Text Key: 319871696
• Report Number: 1818910-2023-15405
• 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: 08/01/2023
• 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