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
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Unspecified Infection (1930)
Date of Event	06/22/2020
Type of Reportable Event	Serious Injury
Additional 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 or Problem 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
• Common Device Name: PROSTHESIS, KNEE, FEMOROTIBIAL, CONSTRAINED, CEMENTED, METAL/POLYMER
• Manufacturer (Section D): MAKO SURGICAL CORP.; 2555 davie road; fort lauderdale FL 33317
• MDR Report Key: 11059971
• Report Number: 0002249697-2020-02753
• Device Sequence Number: 2691632
• Product Code: KRO
• UDI-Device Identifier: 07613327043785
• UDI-Public: 07613327043785
• Combination Product (Y/N): N
• Initial Reporter State: PA
• Initial Reporter Country: US
• PMA/510(K) Number: K994207
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2019
• Device Explanted Year: 2020
• Reporter Type: Manufacturer
• Report Source: health professional,other
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 12/22/2020

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
• Operator of Device: 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
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 12/07/2020
• Initial Report FDA Received Date: 12/22/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention
• Patient Age: 63 YR
• Patient Weight: 61