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

Catalog Number UNK KNEE FEMORAL UNI

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

Patient Problems Adhesion(s) (1695); Stroke/CVA (1770); Hemorrhage/Bleeding (1888); Pain (1994)

Event Date 04/06/2022

Event Type  Injury  

Manufacturer Narrative

Product complaint # (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

Literature article entitled ¿bilateral unicompartmental knee arthroplasty: one stage or two stages?¿ written by biazzo a, masia f, verde f.Published in musculoskelet surg.Published on 2018 dec 3.Pmid: 30511239.The article's purpose was to determine ¿is there an increased risk of perioperative complications with bilateral simultaneous versus unilateral uka? is there a difference in operative times between bilateral simultaneous and unilateral uka? is there a difference in blood loss and rate of blood transfusion?¿ patient data: average age of the patients in group a was 69.5 years, bmi of patients in group a was 29.1.Women were more represented 70 total.Comorbidities: hypertension diabetes and obesity.It is noted that implants in the study were a combination of depuy and competitor products.Cement manufacture is unknown.Depuy products: sigma high performance partial knee (unilateral: poly insert, tibial component and femoral component).Adverse events non-specified patients: significant intra-op blood loss ¿ treated with transfusion of packed red cells intraoperative fracture of the tibial plateau ¿ treated with osteosynthesis orif arthrofibrosis ¿ treated with manipulation under anesthesia transient ischemic attack - no treatment noted regional pain syndrome ¿ oral pain medication and manipulation under anesthesia literature is a valuable source of information.However, it has limitations, including nonspecific and indeterminate information about each adverse event.The authors do not provide information to identify the devices used during primary procedure for each patient.The adverse events captured in this complaint are the events that could be associated with the noted depuy synthes devices.The events that are associated with competitor devices are excluded from this complaint.The actual number and specific product line of depuy synthes devices associated with the above adverse events is unknown.

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 UNI
• 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 orthopaedic dr.; warsaw, IN 46581-0988 ; 3035526892
• MDR Report Key: 14191007
• MDR Text Key: 289956549
• Report Number: 1818910-2022-07368
• Device Sequence Number: 1
• Product Code: JWH
• Combination Product (y/n): N
• Reporter Country Code: IT
• 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: 04/23/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/23/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: UNK KNEE FEMORAL UNI
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 04/29/2022
• 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