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

Catalog Number UNK KNEE TIBIAL INSERT SIGMA

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

Patient Problems Nausea (1970); Nerve Damage (1979); Pain (1994); Vomiting (2144); Impaired Healing (2378); Thrombosis/Thrombus (4440); Swelling/ Edema (4577)

Event Date 04/27/2020

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: wang q, tan g, mohammed a, zhang y, li d, chen l, kang p.Adding corticosteroids to periarticular infiltration analgesia improves the short-term analgesic effects after total knee arthroplasty: a prospective, double-blind, randomized controlled trial.Knee surg sports traumatol arthrosc.2021 mar;29(3):867-875.Doi: 10.1007/s00167-020-06039-9.Epub 2020 may 2.Pmid: 32361928.Objective and methods: patients receiving depuy sigma fixed-bearing or rotating-platform, posterior stabilized total knee prostheses, were randomized to the corticosteroid or control group (double-blinded).The patients in the corticosteroid group received a periarticular infiltration of an analgesic cocktail of ropivacaine, epinephrine, and dexamethasone.Dexamethasone was omitted from the cocktail in the control group.The primary outcomes were postoperative pain [assessed using a visual analog scale (vas)], time until the administration of first rescue analgesia of morphine sulfate, overall morphine consumption, and postoperative inflammatory biomarkers [c-reactive protein (crp) and interleukin-6 (il-6)].The secondary outcomes were functional recovery, assessed by the range of knee motion, quadriceps strength, and daily ambulation distance.The tertiary outcomes included postoperative adverse effects.Results: adding corticosteroids to an analgesic cocktail for pia can mildly improve early pain relief and accelerate recovery in the first 24 h after total knee arthroplasty.Tertiary adverse events (complications): 32: post-op nausea.18: post-op vomiting.28: post-op wound swelling.4: delayed wound healing.3: deep venous thrombosis.9 : chronic pain.2: nerve damage (foot-drop - resolved within 24 hours).

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 SIGMA
• 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 orthopaedic dr.; warsaw, IN 46581-0988 ; 3035526892
• MDR Report Key: 14929534
• MDR Text Key: 295321082
• Report Number: 1818910-2022-12352
• 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: 07/06/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/06/2022
• 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 SIGMA
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 07/07/2022
• 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