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

Catalog Number UNK KNEE PATELLA SIGMA

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

Patient Problems Muscular Rigidity (1968); Loss of Range of Motion (2032)

Event Date 11/30/2019

Event Type  Injury  

Manufacturer Narrative

Product complaint # (b)(4).Investigation summary: no device associated with this report was received for examination.A worldwide lot specific complaint database search, or device history record (dhr) review, was not possible because the required lot number was not provided.Based on previous investigations, this complication of joint replacement is unlikely to have been the result of a device failing to meet required specifications.The information received will be retained for potential series investigations if triggered by trend analysis, post market surveillance, or other events within the quality system.

Event Description

The literature article entitled, "contemporary total hip and total knee arthroplasty results in patients with hemochromatosis" written by afton k.Limberg, bs, brian p.Chalmers, md, kevin i.Perry, md, david g.Lewallen, md, daniel j.Berry, md, and matthew p.Abdel, md published by the journal of arthroplasty made available online on 30 november 2019 was reviewed.The article's purpose was to analyze the survivorship free from any revision, orthopedic and perioperative medical complications, radiographic results and clinical outcomes of primary thas and tkas.Both non depuy and depuy products were included in the data set for both thas and tkas.Data was compiled from 15 patients with primary thas and 14 patients with primary tka.The adverse event noted in the tha group is associated with a non depuy product.The article does not identify the products associated with the adverse events in the tka group.It is noted that 6 tkas utilized pfc sigma and 1 tka utilized attune knee components.Patellar resurfacing was performed in all tkas.Cement manufacturer is not identified.Depuy products: sigma femoral, sigma insert, sigma tibial tray, sigma patella, attune femoral, attune insert, attune tibial tray, attune patella.Adverse event: two patients report of stiffness with limited rom achieving 100 degree of motion post treatment (treated by manipulation under general anesthesia and the other elect no further intervention).

• Brand Name: UNK KNEE PATELLA SIGMA
• Type of Device: KNEE PATELLA
• 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: kara ditty-bovard ; 700 orthopaedic dr; warsaw, IN 46581 ; 6107428552
• MDR Report Key: 11183168
• MDR Text Key: 227746433
• Report Number: 1818910-2021-01310
• Device Sequence Number: 1
• Product Code: OIY
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,literatur
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 01/07/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/17/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: UNK KNEE PATELLA SIGMA
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/07/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention