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U.S. Department of Health and Human Services

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

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DEPUY ORTHOPAEDICS INC US UNK KNEE PATELLA SIGMA Back to Search Results
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).
 
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Brand NameUNK KNEE PATELLA SIGMA
Type of DeviceKNEE 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 Key11183168
MDR Text Key227746433
Report Number1818910-2021-01310
Device Sequence Number1
Product Code OIY
Combination Product (y/n)N
Reporter Country CodeUS
Number of Events Reported1
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 Received01/17/2021
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Catalogue NumberUNK KNEE PATELLA SIGMA
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received01/07/2021
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Is the Device Single Use? No Answer Provided
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

Patient Treatment Data
Date Received: 01/17/2021 Patient Sequence Number: 1
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