MAUDE Adverse Event Report: MAKO SURGICAL CORP. MAKO UKR X3 ONLAY INSERT SIZE 4 - 8 MM; PROSTHESIS, KNEE PATELLOFEMOROTIBIAL, PARTIAL, SEMI-CONSTRAINED, CEMENTED, POLYM

Model Number 180734-1-E

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Unspecified Infection (1930)

Event Date 06/15/2022

Event Type  Injury  

Event Description

It was reported that the patient's right medial pka was revised.As reported: "revision w/ poly exchange.Infection." rep provided primary and revision usage and confirmed that no further information will be released by the hospital or surgeon.

Manufacturer Narrative

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.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.The following devices were also listed in this report: mck femoral-rm-ll-sz 5; cat#180515 ; lot# 4gm1-1.Mck tibial baseplate-rm/ll-sz 4; cat# 180614; lot# 26050321-01.It cannot be determined which, if any of these devices may have caused or contributed to the patient's experience.Device not returned.

• Brand Name: MAKO UKR X3 ONLAY INSERT SIZE 4 - 8 MM
• Type of Device: PROSTHESIS, KNEE PATELLOFEMOROTIBIAL, PARTIAL, SEMI-CONSTRAINED, CEMENTED, POLYM
• Manufacturer (Section D): MAKO SURGICAL CORP.; 2555 davie road; fort lauderdale FL 33317
• Manufacturer (Section G): STRYKER ORTHOPAEDICS-MAHWAH; 325 corporate drive; mahwah NJ 07430
• Manufacturer Contact: anna ryan ; raheen business park; limerick NA ; EI NA ; 61498200
• MDR Report Key: 14878732
• MDR Text Key: 295121378
• Report Number: 3005985723-2022-00087
• Device Sequence Number: 1
• Product Code: NPJ
• UDI-Device Identifier: 07613327385984
• UDI-Public: 07613327385984
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K150307
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 06/30/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/30/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 180734-1-E
• Device Catalogue Number: 180734-1-E
• Device Lot Number: AX5A49
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 06/15/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 12/08/2021
• 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: 59 YR
• Patient Sex: Female
• Patient Weight: 89 KG