MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US UNK KNEE TIBIAL INSERT LCS

Catalog Number UNK KNEE TIBIAL INSERT LCS

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

Patient Problems Erythema (1840); Low Blood Pressure/ Hypotension (1914); Tachycardia (2095); Impaired Healing (2378)

Event Date 01/01/2022

Event Type  Injury  

Manufacturer Narrative

Product complaint #:(b)(4).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

This complaint is from a literature source.The following literature cite has been reviewed: omprakash yadav, munuswamy gurupadham rajesh dhanaskar, & manoj reddy.(2022).Lcs mobile bearing total knee replacement ¿ a minimum 5yrs follow up study in tertiary care hospital, kanchipuram.Journal of pharmaceutical negative results, 102¿110.Https://doi.Org/10.47750/pnr.2022.13.S01.13 objective and methods: the purpose of this retrospective observational study was to investigate the long term outcomes for the depuy lcs mobile bearing tka in 36 patients implanted between 2017 and 2022.The manufacturer of the thas secured with the cement is unknown and it is unknown if the patellas were resurfaced.Lot, model and catalog number are not available, but the suspected depuy device possibly associated with reported adverse events: depuy lcs mobile bearing tka including the femoral component, tibial tray, and tibial insert adverse event(s) and provided interventions associated with depuy devices: 1 prolonged hospital stay due to incision site erythema secondary to delayed wound healing- no invasive treatment provided.1 prolonged hospital stay and admission to the icu to treat postoperative hypotension and tachycardia- no invasive treatment provided.

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 INSERT LCS
• Type of Device: KNEE TIBIAL INSERT
• 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: 16723345
• MDR Text Key: 313168534
• Report Number: 1818910-2023-07742
• Device Sequence Number: 1
• Product Code: JWH
• Combination Product (y/n): N
• Reporter Country Code: IN
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Literature,Health Professional
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 04/12/2023

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 KNEE TIBIAL INSERT LCS
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 03/28/2023
• Initial Date FDA Received: 04/12/2023
• Supplement Dates Manufacturer Received: 05/15/2023
• Supplement Dates FDA Received: 05/15/2023
• 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