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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: DEPUY IRELAND - 9616671 UNK ATTUNE KNEE TIBIAL TRAY

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DEPUY IRELAND - 9616671 UNK ATTUNE KNEE TIBIAL TRAY Back to Search Results
Catalog Number UNK ATTUNE KNEE TIBIAL TRAY
Device Problem Migration (4003)
Patient Problem Insufficient Information (4580)
Event Type  Malfunction  
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

The literature article titled, "a randomized controlled trial comparing tibial migration of the attune cemented cruciate-retaining knee prosthesis with the pfc-sigma design" written by b. L. Kaptein, p. Den hollander, b. Thomasson, m. Fiocco, and r. G. H. H. Nelissen published by the bone and joint journal 2020 was reviewed. The article's purpose was to compare migration of the cemented attune fixed bearing tibial component with the cemented pfc sigma fixed bearing cr tibial component. Data was compiled from 35 attune cases and 33 pfc sigma cases ultimately after some cases were lost in follow up. Any deaths were noted as unrelated. The article focuses solely on the tibial components of each platform for migration measurements. Results were minimal migration found in both groups with detection of radiolucent lines at cement-implant interface in radiographs but no cases were revised for loosening at the time of 2 year follow up. Article reports two generalized adverse events with pfc sigma group but ones adverse event is not related to tka (release of posterior tibial nerve in tarsal tunnel in 2nd postoperative year). Patella resurfacing not discussed and cement manufacturer is not identified. Depuy products: attune tibial tray and pfc sigma tibial tray, pfc sigma femoral, pfc sigma insert. Adverse event for attune tibial tray: radiographic detection of migration (no treatment provided. ) adverse events for pfc sigma group: radiographic detection of migration (no treatment provided. ) infection (treated by arthrotomy, debridement, liner exchange and six weeks of antibiotics. ).

 
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Brand NameUNK ATTUNE KNEE TIBIAL TRAY
Type of DeviceKNEE TIBIAL TRAY
Manufacturer (Section D)
DEPUY IRELAND - 9616671
loughbeg ringaskiddy co.
cork
EI
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 Key11177736
MDR Text Key231801065
Report Number1818910-2021-01248
Device Sequence Number1
Product Code MBH
Combination Product (Y/N)N
Reporter Country CodeNL
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type FOREIGN,HEALTH PROFESSIONAL,L
Reporter Occupation OTHER HEALTH CARE PROFESSIONAL
Type of Report Initial,Followup
Report Date 01/11/2021
1 Device Was Involved in the Event
0 PatientS WERE Involved in the Event:
Date FDA Received01/15/2021
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator HEALTH PROFESSIONAL
Device Catalogue NumberUNK ATTUNE KNEE TIBIAL TRAY
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 Received02/01/2021
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

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