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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH KERBOULL MKIII FEMORAL STEM; PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED
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STRYKER ORTHOPAEDICS-MAHWAH KERBOULL MKIII FEMORAL STEM; PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED Back to Search Results
Catalog Number 4502-101
Device Problem Fracture (1260)
Patient Problems Injury (2348); Ambulation Difficulties (2544)
Event Date 05/06/2020
Event Type  Injury  
Manufacturer Narrative
It was noted that the device is not available for evaluation.If additional information is received, it will be provided in a supplemental report upon completion of the investigation.The event involves a device that is not cleared for sale in the u.S., but similar device is commercially available in the u.S.Device not returned.
 
Event Description
Customer, reported to french health authority ansm that; "operated patient cemented left total hip prosthesis in one piece.Cmk d1 stryker in 2003.Implant fracture on (b)(6) 2020.Revision on (b)(6) 2020." current status of the patient : - change of total hip prosthesis actions undertaken in the health care institution for the care of the patient: conservation of the implant.
 
Manufacturer Narrative
Updated the manufacturing and expiration date.Reported event: an event regarding crack/fracture involving a kerboull stem was reported.The event was not confirmed.Method & results: device evaluation and results: visual, dimensional, functional and material analysis could not be performed as the device was not returned.Clinician review:no medical records were received for review with a clinical consultant.Device history review: device history review indicated the devices accepted into final stock from the reported lot were free from discrepancies.Complaint history review: there has been no other event for the lot referenced.Conclusion: it was reported that the patient was revised due to fractured stem.The event could not be confirmed nor the exact cause be determined because insufficient information was provided.Additional information including device details, operative reports, progress notes, 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.H3 other text : device not returned.
 
Event Description
Customer, reported to french health authority ansm that; "operated patient cemented left total hip prosthesis in one piece.Cmk d1 stryker in 2003.Implant fracture on (b)(6) 2020.Revision on (b)(6) 2020." current status of the patient : change of total hip prosthesis actions undertaken in the health care institution for the care of the patient: conservation of the implant we received the attached request from the ansm.¿ansm is informed of this attached event.This declaration will be processed as part of a statistical signal detection.No meddev final report necessary for this event.Additional question may be asked if necessary.You are reminded that this incident must be considered in your risk analysis.If it were to result in the implementation of a safety corrective action, it should be reported to ansm, according to meddev 2.12-1 rev 8 guide.".
 
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Brand Name
KERBOULL MKIII FEMORAL STEM
Type of Device
PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED
Manufacturer (Section D)
STRYKER ORTHOPAEDICS-MAHWAH
325 corporate drive
mahwah NJ 07430
MDR Report Key10520367
MDR Text Key206504938
Report Number0002249697-2020-01851
Device Sequence Number1
Product Code LPH
Combination Product (y/n)N
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type other
Type of Report Initial,Followup
Report Date 12/09/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator Health Professional
Device Expiration Date09/30/2007
Device Catalogue Number4502-101
Device Lot NumberGA674804
Was Device Available for Evaluation? No
Initial Date Manufacturer Received 08/17/2020
Initial Date FDA Received09/11/2020
Supplement Dates Manufacturer Received11/19/2020
Supplement Dates FDA Received12/09/2020
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Patient Outcome(s) Hospitalization; Required Intervention;
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