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

Catalog Number UNK KNEE FEMORAL SIGMA PS

Device Problems Adverse Event Without Identified Device or Use Problem (2993); Patient Device Interaction Problem (4001)

Patient Problems Unspecified Infection (1930); Nerve Damage (1979); Unspecified Tissue Injury (4559)

Event Date 05/11/2021

Event Type  Injury  

Manufacturer Narrative

Product complaint # (b)(4).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: zhao ez, zeng wn, ding zc, liu zh, luo zy, zhou zk.A comparison between unstemmed and stemmed constrained condylar knee prostheses in primary total knee arthroplasty: a propensity score-matched analysis.Orthop surg.2022 feb;14(2):246-253.Doi: 10.1111/os.13093.Epub 2021 dec 13.Pmid: 34898021; pmcid: pmc8867417.Objective and methods: authors compared clinical outcomes of primary stemmed versus non-stemmed constrained condylar knee (cck) prosthesis with respect to implant survivorship, change in outcome evaluations, and complications.Depuy pfc sigma tc3 femur and tibial implants were utilized, with 25 patients receiving unstemmed implants, and 81 receiving stemmed implants.There is no indication that the patella was resurfaced in any circumstance.Results: at 7 years follow-up, there was no significant difference in the clinical outcomes and survivorship between the stemmed and non-stemmed knee recipients.Unstemmed cck prosthesis are suitable for patients with good bone stock.The following complications were reported: 2: superficial infections, treated with antibiotics, surgical i&d (no implant exchange) ¿ stemmed group.1: peroneus communis nerve palsy, treated with neurotrophic therapy ¿ unstemmed group.1: patella baja/clunk syndrome, treated with arthroscopic debridement ¿ unstemmed group.1: periprosthetic infection, revision washout and insert exchange ¿ stemmed group.

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 FEMORAL SIGMA PS
• 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: 14999708
• MDR Text Key: 295776384
• Report Number: 1818910-2022-12877
• Device Sequence Number: 1
• Product Code: JWH
• Combination Product (y/n): N
• Reporter Country Code: CH
• 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: 07/13/2022

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?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: UNK KNEE FEMORAL SIGMA PS
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 06/25/2022
• Initial Date FDA Received: 07/13/2022
• Supplement Dates Manufacturer Received: 08/23/2022
• Supplement Dates FDA Received: 08/24/2022
• 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