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U.S. Department of Health and Human Services

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

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DEPUY ORTHOPAEDICS INC US UNK KNEE TIBIAL TRAY SIGMA Back to Search Results
Catalog Number UNK KNEE TIBIAL TRAY SIGMA
Device Problem Migration (4003)
Patient Problem Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)
Event Type  Injury  
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 KNEE TIBIAL TRAY SIGMA
Type of DeviceKNEE TIBIAL TRAY
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 Key11177734
MDR Text Key227050211
Report Number1818910-2021-01249
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
1 Patient Was Involved in the Event
Date FDA Received01/15/2021
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? Yes
Device Operator HEALTH PROFESSIONAL
Device Catalogue NumberUNK KNEE TIBIAL TRAY 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 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

Patient TREATMENT DATA
Date Received: 01/15/2021 Patient Sequence Number: 1
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