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

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.

• Brand Name: MRHK TIB INS 10MM XS/S S1/S2
• Type of Device: PROSTHESIS, 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 Key: 11059971
• MDR Text Key: 223372353
• Report Number: 0002249697-2020-02753
• Device Sequence Number: 1
• Product Code: KRO
• UDI-Device Identifier: 07613327043785
• UDI-Public: 07613327043785
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K994207
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,other
• Reporter Occupation: Physician
• 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 Received: 12/22/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 01/31/2024
• Device Model Number: 6481-3-210
• Device Catalogue Number: 64813210
• Device Lot Number: LJA482
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 12/07/2020
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 01/25/2019
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 63 YR
• Patient Weight: 61