MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US UNK KNEE FEMORAL SIGMA; FEMORAL

Catalog Number UNK KNEE FEMORAL SIGMA

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

Patient Problems Wound Dehiscence (1154); Impaired Healing (2378)

Event Date 08/10/2021

Event Type  Injury  

Event Description

This complaint is from a literature source.The following literature cite has been reviewed: shakya a, singh v, agrawal ra, sharma a, mangale n, wadgave v, jaiswal a.A mid-term comparison of the functional outcomes of medial pivot and rotating platform mobile-bearing total knee arthroplasty in the indian population.Indian j orthop.2021 aug 10;56(2):271-279.Doi: 10.1007/s43465-021-00472-9.Pmid: 35140858; pmcid: pmc8789967.Objective and methods: both medial pivot (mp) and rotating platform (rp) mobile-bearing (mb) total knee arthroplasty (tka) have been developed to better mimic the natural knee kinematics and femoral roll back in flexion.The purpose of this retrospective study was to compare the mid-term functional outcomes and range of motion (rom) of competitor mp and depuy rp types of total knee arthroplasty.The authors included 116 patients who were implanted between january 2013 and may 2015: 54 belonged to the competitor mp group and 62 to the depuy pfc sigma rp group.The patellas were selectively resurfaced according to surgeon preference and the cement utilized is unknown.This complaint will only include the results associated with the depuy devices.Lot, model and catalog number are not available, but the suspected depuy device possibly associated with reported adverse events: pfc sigma tka including a femoral component, tibial insert, tibial tray, and possible patellar button adverse event(s) and provided interventions associated with depuy devices: 1 case of wound dehiscence and delayed healing treated with debridement.3 cases of non-progressive rlls.No treatment required and location of lines was not specified.

Manufacturer Narrative

Product complaint (b)(4).D4-the device catalog number is unknown; therefore, udi is unavailable.This report is being submitted pursuant to the provisions of 21 cfr, part 803 (and/or part 4, as applicable).This report may be based on information which has not been investigated or verified prior to the required reporting date.This report does not reflect a conclusion by depuy synthes, or its employees that the report constitutes an admission that the product, 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 report, a follow-up report 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.As part of our company quality system process, all devices are manufactured, inspected, and distributed to approved specifications.Additional complaint information monitoring for potential safety signals will be conducted through complaint trending as part of the post-market surveillance.If additional information is made available, the investigation will be updated as applicable.Device history lot: the device lot number is unknown, therefore a device history review could not be performed.If the lot/serial number becomes available, the record will be re-assessed.

• Brand Name: UNK KNEE FEMORAL SIGMA
• Type of Device: FEMORAL
• 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: 18107086
• MDR Text Key: 327875401
• Report Number: 1818910-2023-22990
• 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: 11/09/2023

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 FEMORAL SIGMA
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 10/20/2023
• Initial Date FDA Received: 11/09/2023
• Supplement Dates Manufacturer Received: 11/10/2023
• Supplement Dates FDA Received: 11/13/2023
• 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