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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH MRS SM FEM STEM 10 X 102MM PROSTHESIS, KNEE, FEMOROTIBIAL, CONSTRAINED, CEMENTED, METAL/POLYMER

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STRYKER ORTHOPAEDICS-MAHWAH MRS SM FEM STEM 10 X 102MM PROSTHESIS, KNEE, FEMOROTIBIAL, CONSTRAINED, CEMENTED, METAL/POLYMER Back to Search Results
Model Number 6485-3-000
Device Problems Fracture (1260); Failure to Osseointegrate (1863)
Patient Problems Ambulation Difficulties (2544); Inadequate Osseointegration (2646)
Event Date 10/12/2020
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. Device not returned.
 
Event Description
It was reported by the sales rep that the surgeon informed of an issue of a broken gmrs stem on 26oct2020 (current stem diameter 10mm ref 6485-3-000, ln 187138a) and the need to revise to a thicker stem (11 or 13mm). Current stem was implanted on (b)(6) 2019 (primary surgery). Revision surgery is planned on (b)(6) 2020. Update: "surgeon mentioned implant likely have loosened and broken due to patient riding motorcycle and using her legs to stop the bike (excessive stress to implant) patient had broken implant in (b)(6) 2020 but was unable to come in due to covid, hence the delay to nov surgery. ".
 
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Brand NameMRS SM FEM STEM 10 X 102MM
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
daniela davila
2555 davie road
centennial park, elstree
fort lauderdale, FL 33317
9546280700
MDR Report Key10854626
MDR Text Key216845300
Report Number0002249697-2020-02475
Device Sequence Number1
Product Code KRO
Combination Product (y/n)N
Reporter Country CodeSN
PMA/PMN Number
K040749
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 01/11/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received11/17/2020
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Model Number6485-3-000
Device Catalogue Number64853000
Device Lot Number187138A
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 Received12/15/2020
Was Device Evaluated by Manufacturer? No
Date Device Manufactured01/08/2018
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: 11/17/2020 Patient Sequence Number: 1
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