MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US UNK KNEE TIBIAL TRAY SIGMA

Catalog Number UNK TIBIAL TRAY SIGMA

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Adhesion(s) (1695); Pain (1994); Unspecified Musculoskeletal problem (4535)

Event Date 03/07/2023

Event Type  Injury  

Event Description

This complaint is from a literature source.The following literature cite has been reviewed: kleeman-forsthuber lt, angerame m, jennings j, lundy k, brady a, dennis da.High incidence of recurrent patellofemoral crepitus in total knee arthroplasty patients following arthroscopic debridement.Arthroplast today.2023 mar 7;20:101112.Doi: 10.1016/j.Artd.2023.101112.Pmid: 36938348; pmcid: pmc10018431.Objective and methods: patellofemoral crepitus is an unfavorable complication following total knee arthroplasty (tka) with a posterior-stabilized (ps) implant.The purpose of this study was to study patellar crepitus recurrence and reoperation rates following arthroscopic debridement in patients with a ps-tka.Of the 16 patients captured in this complaint, 14 received a pfc sigma, 1 received an attune ps, and 1 received a competitor product.All patient had resurfaced patellas and the manufacturer of the cement utilized is unknown.The authors define ¿symptomatic¿ as patellar crepitus associated with severe pain and walking difficulty.All the recurrent patellar crepitus was caused by arthrofibrosis.All recurrent crepitus patients had periarticular corticosteroid injections and physical therapy.The authors note that some patients also had patellar clunk but do not provide sufficient information to associate patellar clunk with specific patients.This complaint will capture the 15 patients with depuy tkas detailed in the study.Patient 7 is excluded as they received a competitor construct.Results: patient 2: patient with pfc sigma ps tka with a 35 mm patella and size 4 femoral component reported asymptomatic patellar crepitus secondary to arthrofibrosis.The patellar crepitus resolved without sequalae.

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.

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: UNK KNEE TIBIAL TRAY SIGMA
• Type of Device: KNEE TIBIAL TRAY
• Manufacturer (Section D): DEPUY ORTHOPAEDICS INC US; 700 orthopaedic drive; warsaw IN 46581 0988
• Manufacturer (Section G): DEPUY ORTHOPAEDICS 1818910; 700 orthopaedic dr; warsaw IN 46581 0988
• Manufacturer Contact: kate karberg ; 700 orthopaedic dr.; warsaw, IN 46581-0988 ; 3035526892
• MDR Report Key: 16829599
• MDR Text Key: 314163366
• Report Number: 1818910-2023-08934
• Device Sequence Number: 1
• Product Code: LPH
• 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: 04/27/2023

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 Catalogue Number: UNK TIBIAL TRAY SIGMA
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 04/17/2023
• Initial Date FDA Received: 04/28/2023
• Supplement Dates Manufacturer Received: 04/28/2023
• Supplement Dates FDA Received: 04/30/2023
• 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
• Treatment: UNK CEMENT; UNK KNEE FEMORAL COMPONENT; UNK KNEE PATELLA; UNK KNEE TIBIAL INSERT; UNK KNEE TIBIAL TRAY
• Patient Outcome(s): Required Intervention