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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH DURDURT TS TIB INS LG 11MM; PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/META
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STRYKER ORTHOPAEDICS-MAHWAH DURDURT TS TIB INS LG 11MM; PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/META Back to Search Results
Catalog Number 6642-5-311
Device Problem Degraded (1153)
Patient Problem Injury (2348)
Event Date 01/08/2019
Event Type  Injury  
Manufacturer Narrative
It was noted that the device is not available for evaluation.Should additional information become available, it will be provided in a supplemental report upon completion of the investigation.Device not available.
 
Event Description
It was reported that the patient's right knee was revised due to excessive insert wear.Surgeon reported contributing factors: implanted for 14 years, and patient weight gain of over 200 pounds.A large duracon 11mm insert was revised to a large duracon 28mm insert.Rep provided the primary operative report, pre-revision x-ray, revision implant sheet, and device pictures and reported that no further information will be available.
 
Manufacturer Narrative
An event regarding wear involving a duracon insert was reported.The event was confirmed based on the images provided.Method & results: -device evaluation and results: no product was returned for evaluation however photographs were provided for review.The photographs show a recently explanted insert.Blood and explantation damage is visible on the insert with wear visible along the lateral compartment (right knee).Some of the photographs show the insert with the stabilizer support bracket attached and some photographs show the insert with the support bracket removed.-medical records received and evaluation: a review of the provided medical records was rejected for medical review by a clinical consultant who stated the following comment: need revision operative report and serial x-rays.-device history review: could not be performed as lot code information was not provided.-complaint history review: could not be performed as lot code information was not provided.Conclusion: while the wear on the component could be confirmed through review of the provided photographs, the exact cause of the event could not be confirmed.It is noted that the implant had been in situ and it is also reported that the patient had gained over 200 pounds since primary surgery however, additional information including revision operative report, serial x-rays and return of the device are needed to fully investigate the event.If further information becomes available or the product is returned, this investigation will be re-opened.
 
Event Description
It was reported that the patient's right knee was revised due to excessive insert wear.Surgeon reported contributing factors: implanted for 14 years, and patient weight gain of over 200 pounds.A large duracon 11mm insert was revised to a large duracon 28mm insert.Rep provided the primary operative report, pre-revision x-ray, revision implant sheet, and device pictures and reported that no further information will be available.
 
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Brand Name
DURDURT TS TIB INS LG 11MM
Type of Device
PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/META
Manufacturer (Section D)
STRYKER ORTHOPAEDICS-MAHWAH
325 corporate drive
mahwah NJ 07430
MDR Report Key8304872
MDR Text Key134997980
Report Number0002249697-2019-00483
Device Sequence Number1
Product Code JWH
UDI-Device Identifier04546540318916
UDI-Public04546540318916
Combination Product (y/n)N
PMA/PMN Number
K973164
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type health professional,other
Type of Report Initial,Followup
Report Date 04/18/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received02/05/2019
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator No Information
Device Catalogue Number6642-5-311
Device Lot NumberUNKNOWN
Was Device Available for Evaluation? No
Date Manufacturer Received03/20/2019
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Patient Outcome(s) Hospitalization; Required Intervention;
Patient Age60 YR
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