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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH GMRS SMALL AXLE PROSTHESIS, KNEE, FEMOROTIBIAL, CONSTRAINED, CEMENTED, METAL/POLYMER

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STRYKER ORTHOPAEDICS-MAHWAH GMRS SMALL AXLE PROSTHESIS, KNEE, FEMOROTIBIAL, CONSTRAINED, CEMENTED, METAL/POLYMER Back to Search Results
Catalog Number 64952115
Device Problems Fracture (1260); Device Damaged by Another Device (2915); Noise, Audible (3273)
Patient Problem Injury (2348)
Event Date 05/01/2017
Event Type  Injury  
Manufacturer Narrative
An event regarding crack/fracture involving a gmrs axle was reported. The event was confirmed based on photographs provided. Method & results: device evaluation and results: visual inspection was only carried out on the photographs provided by the surgeon. The explanted tibial gmrs device with fractured axle. The polyethylene bumper is missing. Nothing of noted could be seen on the photograph provided. No items were returned. Medical records received and evaluation: a review of the medical records by a clinician indicated that: very high activity level of the patient including high level sports caused the poly bumper in the mrh knee section to fail progressively after which an overload condition developed in axle area with ultimately an axle fracture due to hard-hard metal device contact not anymore subject to shock absorption by the poly bumper. Procedure-related factors:- poly bumper end-of-service life under high loading conditions. Patient-related factors- very high activity level including high level sports device-related factors:- none evident. Device history review: a review indicated that all devices were manufactured and accepted into final stock with no relevant reported discrepancies. Complaint history review: there have been no other events for the lot referenced. Conclusions: the medical review indicates that the very high activity level of the patient including high level sports caused the poly bumper in the mrh knee section to fail progressively after which an overload condition developed in axle area with ultimately an axle fracture due to hard-hard metal device contact not anymore subject to shock absorption by the poly bumper. No further investigation is required at this time. If additional information such as becomes available to indicate further evaluation is warranted, this record will be reopened.
 
Event Description
Sales rep reported a very active young male, active volleyball player felt a clicking sound in knee.
 
Manufacturer Narrative
It was noted that the device is not available for evaluation. Additional information has been requested and if received, will be provided in the supplemental report upon completion of the investigation. Review of the device history records indicate devices were manufactured and accepted into final stock with no reported discrepancies. There have been no other events for the lot referenced.
 
Event Description
Sales rep reported a very active young male, active volleyball player felt a clicking sound in knee.
 
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Brand NameGMRS SMALL AXLE
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
Manufacturer Contact
cindy chuhinko
325 corporate drive
mahwah, NJ 07430
2018315000
MDR Report Key6595539
MDR Text Key206475898
Report Number0002249697-2017-01692
Device Sequence Number1
Product Code KRO
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K023087
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type health professional,other
Reporter Occupation
Type of Report Initial,Followup
Report Date 08/02/2017
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received05/26/2017
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Expiration Date02/26/2020
Device Catalogue Number64952115
Device Lot NumberCTD5845
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 Received07/14/2017
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured02/26/2015
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: 05/26/2017 Patient Sequence Number: 1
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