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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MAKO SURGICAL CORP. MRHK TIB INS 10MM XS/S S1/S2 PROSTHESIS, KNEE, FEMOROTIBIAL, CONSTRAINED, CEMENTED, METAL/POLYMER

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MAKO SURGICAL CORP. 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 Unspecified Infection (1930)
Event Date 06/22/2020
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. 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. The following devices were also listed in this report: gmrs dist fem comp sml r 65mm; cat# 64952020; lot# ep99n. Mrh tib rot comp xs-xl; cat# 64812100; lot# 144654. Mrhk tibial sleeve; cat# 64812140 ; lot# ljb100. Gmrs small femoral bushing; cat# 64952105; lot# lhr135. Gmrs extension piece 80mm; cat# 64956080; lot# exj9t. Mrhk bumper insert 3 degrees; cat# 64812133; lot# lhp365. Gmrs small axle; cat# 64952115; lot# ctd29357. Gmrs small femoral bushing; cat# 64952105; lot# lhs100. It cannot be determined which, if any of these devices may have caused or contributed to the patient's experience.
 
Event Description
Procedure: the patient had right knee replacement outside cors scope. Patient underwent revision of removal of antibiotic spacer and right distal femur replacing oncologic megaprosthesis (b)(6) 2018. The patient underwent revision of right lower extremity infected megaprosthesis (b)(6) 2019. Patient got reinfection of right tka and underwent resection of all components on (b)(6) 2020. Patient then had reimplantation on (b)(6) 2020.
 
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Brand NameMRHK TIB INS 10MM XS/S S1/S2
Type of DevicePROSTHESIS, KNEE, FEMOROTIBIAL, CONSTRAINED, CEMENTED, METAL/POLYMER
Manufacturer (Section D)
MAKO SURGICAL CORP.
2555 davie road
fort lauderdale FL 33317
Manufacturer (Section G)
STRYKER ORTHOPAEDICS-LIMERICK
raheen business park
limerick NA
EI NA
Manufacturer Contact
brad curtis
325 corporate drive
mahwah, NJ 07430
2018315000
MDR Report Key11059971
MDR Text Key223372353
Report Number0002249697-2020-02753
Device Sequence Number1
Product Code KRO
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,other
Reporter Occupation
Type of Report Initial
Report Date 12/22/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received12/22/2020
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Model Number6481-3-210
Device Catalogue Number64813210
Device Lot NumberLJA482
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 Received12/07/2020
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured01/25/2019
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: 12/22/2020 Patient Sequence Number: 1
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