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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH MRS FEM ROT HINGE RT 65MM BOD PROSTHESIS, KNEE, FEMOROTIBIAL, CONSTRAINED, CEMENTED, METAL/POLYMER

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STRYKER ORTHOPAEDICS-MAHWAH MRS FEM ROT HINGE RT 65MM BOD PROSTHESIS, KNEE, FEMOROTIBIAL, CONSTRAINED, CEMENTED, METAL/POLYMER Back to Search Results
Catalog Number 2481-8-020
Device Problems Corroded (1131); Metal Shedding Debris (1804)
Patient Problems Inflammation (1932); Injury (2348); Reaction (2414)
Event Date 10/03/2017
Event Type  Injury  
Manufacturer Narrative
Review of the device history records indicate that devices were manufactured and accepted into final stock with reported discrepancies. There has been no other events for the lot referenced. An event regarding tibial loosening involving an mrs femoral component was reported. The material analysis report confirmed corrosion. Method & results: -device evaluation and results: material analysis of returned device was performed and indicated that debris was observed on the femoral component of the implant. Eds showed the femoral component was consistent with astm f75 alloy and the debris was consistent with a corrosion process and biological material. No material or manufacturing defects were observed on the surfaces examined. -medical records received and evaluation: no medical records or x-rays were made available for evaluation. -device history review: a device history review confirmed all devices accepted into finished goods conformed to specification. -complaint history review: no other events were reported for the lot indicated. Conclusions: an event regarding tibial loosening involving an mrs femoral component was reported. The material analysis report was confirmed to corrosion. Material analysis of returned device was performed and indicated that debris was observed on the femoral component of the implant. Eds showed the femoral component was consistent with astm f75 alloy and the debris was consistent with a corrosion process and biological material. Further information such as pre- and post-op x-rays, patient history, histopathology report & follow-up notes are needed to investigate this event further. If additional information become available, this investigation will be re-opened.
 
Event Description
Revision of mrs distal femoral replacement w/ all poly tibia for tibial loosening. Event update per review of the material analysis performed on (b)(6) 2017: "debris was observed on the femoral component of the implant. Eds showed the femoral component was consistent with astm f75 alloy and the debris was consistent with a corrosion process and biological material. No material or manufacturing defects were observed on the surfaces examined. ".
 
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Brand NameMRS FEM ROT HINGE RT 65MM BOD
Type of DevicePROSTHESIS, KNEE, FEMOROTIBIAL, CONSTRAINED, CEMENTED, METAL/POLYMER
Manufacturer (Section D)
STRYKER ORTHOPAEDICS-MAHWAH
325 corporate drive
mahwah NJ 07430
Manufacturer (Section G)
STRYKER ORTHOPAEDICS-MAHWAH
325 corporate drive
mahwah NJ 07430
Manufacturer Contact
juana hiciano
325 corporate drive
mahwah, NJ 07430
2018315000
MDR Report Key7204096
MDR Text Key97707548
Report Number0002249697-2018-00203
Device Sequence Number1
Product Code KRO
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K952970
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative
Reporter Occupation
Type of Report Initial
Report Date 01/18/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received01/18/2018
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Expiration Date06/16/2002
Device Catalogue Number2481-8-020
Device Lot NumberEUSVA
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer10/18/2017
Is the Reporter a Health Professional?
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received12/21/2017
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured06/16/1997
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

Patient Treatment Data
Date Received: 01/18/2018 Patient Sequence Number: 1
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