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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH MRHK BUMPER INSERT - NEUTRAL PROSTHESIS, KNEE, FEMOROTIBIAL, CONSTRAINED, CEMENTED, METAL/POLYMER

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STRYKER ORTHOPAEDICS-MAHWAH MRHK BUMPER INSERT - NEUTRAL PROSTHESIS, KNEE, FEMOROTIBIAL, CONSTRAINED, CEMENTED, METAL/POLYMER Back to Search Results
Model Number 6481-2-130
Device Problems Degraded (1153); Adverse Event Without Identified Device or Use Problem (2993)
Patient Problem Pain (1994)
Event Date 11/20/2020
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 review of the device history records indicate devices were manufactured and accepted into final stock with no relevant reported discrepancies. There have been no other similar events for the lot referenced. Catalog numbers and lot codes of other devices listed in this report: 64812140, mrhk tibial sleeve, lot lcl758. 64952105, gmrs small femoral bushing, lot lcw343. 64952105, gmrs small femoral bushing, lot lcn680. 64813210, mrhk tib ins 10mm xs/s s1/s2, lot lcs554. 64952115, gmrs small axle, lot ctd777. 64812100, mrh tib rot comp xs-xl, lot 023234. It cannot be determined which, if any of these devices may have caused or contributed to the patient's experience.
 
Event Description
As reported: "patient had pain. X-rays showed potential damage to bumper and bushings. Surgeon performed poly swap to exchange the sleeve, insert, rotating component, two bushings, axle and bumper. " right side. Spoke to rep, who provided a picture of the explants and x-rays. Rep confirmed that no further information will be released by the hospital or surgeon.
 
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Brand NameMRHK BUMPER INSERT - NEUTRAL
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-LIMERICK
raheen business park
limerick NA
EI NA
Manufacturer Contact
diana rogers
210 centennial avenue
centennial park, elstree
borehamwood WD6 3-SJ
UK   WD6 3SJ
2082386500
MDR Report Key10987632
MDR Text Key220902954
Report Number0002249697-2020-02636
Device Sequence Number1
Product Code KRO
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K002552
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type health professional
Reporter Occupation
Type of Report Initial,Followup
Report Date 01/18/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received12/10/2020
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Expiration Date08/31/2016
Device Model Number6481-2-130
Device Catalogue Number64812130
Device Lot NumberLCO137
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
Date Device Manufactured08/24/2011
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: 12/10/2020 Patient Sequence Number: 1
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