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

Catalog Number UNK KNEE TIBIAL TRAY

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

Patient Problems Arrhythmia (1721); Stroke/CVA (1770); Bone Fracture(s) (1870); Hemorrhage/Bleeding (1888); Loss of Range of Motion (2032); Renal Failure (2041); Impaired Healing (2378); Thrombosis/Thrombus (4440); Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)

Event Type  Injury  

Manufacturer Narrative

(b)(4).If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

Event Description

Article entitled ¿hospital frailty risk score predicts adverse events in primary total hip and knee arthroplasty" written by matthias meyer, md, lukas parik, md, franziska leiss, md, and tobias renkawitz, md published by the journal of arthroplasty accepted on june 30, 2020 was reviewed.The articles purpose was to determine the utility of the hfrs as a predictor for postoperative adverse events after primary total hip (tha) and knee (tka) arthroplasty.4558 thas and 3692 tkas were performed at a high volume arthroplasty center.Press-fit acetabular components and cement-free stems of one single manufacturer (pinnacle cup, corail, or trilock stem; depuy, warsaw, in) were used in all thas.Cemented tka was performed through a medial parapatellar approach.Cemented components of one single manufacturer (pfc sigma; depuy) were used in all tkas.No patella resurfacing was performed.A retrospective analysis between 2011 and 2019 of the hfrs was calculated for each patient.Reoperation rates, readmission rates, complication rates, and transfusion rates were compared between patients with low and intermediate or high frailty risk.The study determined that hfrs predicts adverse events after tha and tka and therefore allows hospitals to identify at-risk patients without extra effort or expense.Findings: adverse events after tha: 198 patients required reoperation within 90 days.177 patients required readmission to the hospital within 90 days.57 patients diagnosed with a periprosthetic fracture.22 patients diagnosed with luxation.38 patients diagnosed with a wound healing disorder.5 patients diagnosed with a joint infection.3 patients diagnosed with acute coronary syndrome.9 patients diagnosed with decompensated heart failure.21 patients diagnosed with cardiac arrythmia.24 patients diagnosed with acute renal failure.11 patients diagnosed with thrombosis.7 patients diagnosed with pulmonary embolism.33 patients diagnosed with collapse.4 patients diagnosed with cerebrovascular accident.68 patients diagnosed with postoperative delirium.71 patients diagnosed with clavien-dindo iv.82 patients required a transfusion.Adverse events after tka: 169 patients required reoperation within 90 days.196 patients required readmission to the hospital within 90 days.14 patients diagnosed with a periprosthetic fracture.12 patients diagnosed with insufficient range of motion.33 patients diagnosed with a wound healing disorder.2 patients diagnosed with a joint infection.4 patients diagnosed with acute coronary syndrome.2 patients diagnosed with decompensated heart failure.15 patients diagnosed with cardiac arrythmia.24 patients diagnosed with acute renal failure.14 patients diagnosed with thrombosis.8 patients diagnosed with pulmonary embolism.47 patients diagnosed with collapse.7 patients diagnosed with cerebrovascular accident.55 patients diagnosed with postoperative delirium.60 patients diagnosed with clavien-dindo iv.59 patients required a transfusion.Depuy products: unknown acetabular cup pinnacle.Unknown acetabular liner.Unknown femoral head.Unknown femoral stem corail.Unknown femoral stem trilock.Unknown knee femoral sigma.Unknown knee tibial insert sigma.Unknown knee tibial tray sigma.

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
• MDR Report Key: 12347800
• MDR Text Key: 267447895
• Report Number: 1818910-2021-18250
• Device Sequence Number: 1
• Product Code: JWH
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,l
• Type of Report: Initial,Followup
• Report Date: 08/02/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/20/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: UNK KNEE TIBIAL TRAY
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 08/25/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention