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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH MRHK TIB INS 10MM XS/S S1/S2; PROSTHESIS, KNEE, FEMOROTIBIAL, CONSTRAINED, CEMENTED, METAL/POLYMER
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STRYKER ORTHOPAEDICS-MAHWAH MRHK TIB INS 10MM XS/S S1/S2; PROSTHESIS, KNEE, FEMOROTIBIAL, CONSTRAINED, CEMENTED, METAL/POLYMER Back to Search Results
Model Number 6481-3-210
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problem Fluid Discharge (2686)
Event Date 12/13/2021
Event Type  Injury  
Event Description
It was reported the patient's left knee was revised.As reported: "pt.Presented with a draining wound, of a previous surgical incision.Performed an i&d of the wound." a tibial sleeve, axle, rotating component, tibial insert, bumper insert, and 2 femoral bushings were revised.
 
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 wi th no relevant reported discrepancies.There have been no other similar events for the lot referenced.The following devices were also listed in this report: mrhk tibial sleeve, cat#: 64812140, lot#: lkp086.Mrh tib rot comp xs-xl, cat#: 64812100, lot#:180638.Gmrs small axle, cat#: 64952115, lot#: ctd59683.Mrhk bumper insert - neutral, cat#: 64812130, lot#: lkt509.Gmrs small femoral bushing, cat#: 64952105, lot#: lkr836.Gmrs small femoral bushing, cat#: 64952105, lot#: lkr836.15mm press fit fluted stem, cat#: 6495-5-015, lot#: 230792b.Gmrs extension piece 140mm, cat#: 64956140, lot#: ht36j.Gmrs extension piece 50mm, cat#: 64956050, lot#: nh44p.Gmrs dist fem comp sml l 65mm, cat#: 64952010, lot#: lel3h.Mrh tibial b/plt keel sml 2, cat#: 64813111, lot#: lec6b.Ti dur reg fluted stem 10x80mm, cat#: 64786600, lot#: 0048396.It cannot be determined which, if any of these devices may have caused or contributed to the patient's experience.
 
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 wi th no relevant reported discrepancies.There have been no other similar events for the lot referenced.The following devices were also listed in this report: mrhk tibial sleeve, cat#: 64812140, lot#: lkp086.Mrh tib rot comp xs-xl, cat#: 64812100, lot#:180638.Gmrs small axle, cat#: 64952115, lot#: ctd59683.Mrhk bumper insert - neutral, cat#: 64812130, lot#: lkt509.Gmrs small femoral bushing, cat#: 64952105, lot#: lkr836.Gmrs small femoral bushing, cat#: 64952105, lot#: lkr836.15mm press fit fluted stem, cat#: 6495-5-015, lot#: 230792b.Gmrs extension piece 140mm, cat#: 64956140, lot#: ht36j.Gmrs extension piece 50mm, cat#: 64956050, lot#: nh44p.Gmrs dist fem comp sml l 65mm, cat#: 64952010, lot#: lel3h.Mrh tibial b/plt keel sml 2, cat#: 64813111, lot#: lec6b.Ti dur reg fluted stem 10x80mm, cat#: 64786600, lot#: 0048396.It cannot be determined which, if any of these devices may have caused or contributed to the patient's experience.
 
Event Description
It was reported the patient's left knee was revised.As reported: "pt.Presented with a draining wound, of a previous surgical incision.Performed an i&d of the wound." a tibial sleeve, axle, rotating component, tibial insert, bumper insert, and 2 femoral bushings were revised.
 
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Brand Name
MRHK TIB INS 10MM XS/S S1/S2
Type of Device
PROSTHESIS, 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
arokiya raj
325 corporate drive
mahwah, NJ 07430
2018315000
MDR Report Key13182215
MDR Text Key286044937
Report Number0002249697-2022-00031
Device Sequence Number1
Product Code KRO
UDI-Device Identifier07613327043785
UDI-Public07613327043785
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K994207
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Health Professional
Reporter Occupation Physician
Type of Report Initial
Report Date 01/06/2022
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 Model Number6481-3-210
Device Catalogue Number64813210
Device Lot NumberLJP798
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Initial Date Manufacturer Received 12/13/2021
Initial Date FDA Received01/06/2022
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured11/06/2019
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Patient Sequence Number1
Patient Outcome(s) Required Intervention; Hospitalization;
Patient Age55 YR
Patient SexFemale
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