MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US UNKNOWN KNEE FEMORAL

Catalog Number UNK KNEE FEMORAL

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

Patient Problems Pulmonary Embolism (1498); Arrhythmia (1721); Fatigue (1849); Hemorrhage/Bleeding (1888); Pneumonia (2011); Sepsis (2067); Urinary Retention (2119); Urinary Tract Infection (2120); Post Operative Wound Infection (2446); Unspecified Mental, Emotional or Behavioural Problem (4430); Renal Impairment (4499); Physical Asymmetry (4573); Insufficient Information (4580)

Event Date 11/09/2020

Event Type  Injury  

Event Description

Article entitled "earlier initiation of postoperative physical therapy decreases opioid use after total knee arthroplasty" written by tal frenkel rutenberg, md, haim izchak, yoav rosenthal, md, uri barak md, shai shemesh md and snir heller md published in thieme medical on november 9, 2020 was reviewed.The purpose of the study was to compare the outcome of early versus delayed pt regimens following tka.In this study, 205 consecutive patients who underwent tka due to knee osteoarthritis between january 1, 2014 and december 31, 2015.Sigma pfc was placed in all patients ¿ no mention of patella implantation or cement usage.One-hundred and thirty-six patients have started pt on pod1 and 69 patients on pod3.Adverse events: post-op blood transfusion provided ¿ no mention of patient involvement.4 patients experienced a pulmonary embolus ¿ no mention of treatment involved.2 patients experienced a urinary tract infection ¿ no mention of treatment involved.1 patient experienced pneumonia ¿ no mention of treatment involved.5 patients experienced atrial fibrillation ¿ no mention of treatment involved.4 patients experienced urinary retention ¿ no mention of treatment involved.7 patients experienced acute renal failure ¿ no mention of treatment involved.1 patient experienced sepsis ¿ no mention of treatment involved.1 patient experienced delirium ¿ no mention of treatment involved.10 patients experienced ¿other medical complications¿ ¿ no mention of treatment involved 2 patients experienced superficial wound infection ¿ no mention of treatment involved.2 patients experienced sensory deficit around the knee ¿ no mention of treatment involved.1 patient experienced clunk syndrome ¿ no mention of treatment involved.1 patient experienced leg length difference ¿ no mention of treatment involved.1 patient experienced minimal muscle weakness ¿ no mention of treatment involved.

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.

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: UNKNOWN KNEE FEMORAL
• Type of Device: KNEE 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 orthopaedic dr.; warsaw, IN 46581-0988 ; 3035526892
• MDR Report Key: 14852707
• MDR Text Key: 294944595
• Report Number: 1818910-2022-11988
• Device Sequence Number: 1
• Product Code: JWH
• Combination Product (y/n): N
• Reporter Country Code: IS
• 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: 06/29/2022

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?: No
• Device Operator: Health Professional
• Device Catalogue Number: UNK KNEE FEMORAL
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 06/16/2022
• Initial Date FDA Received: 06/29/2022
• Supplement Dates Manufacturer Received: 07/04/2022
• Supplement Dates FDA Received: 07/05/2022
• 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