MAUDE Adverse Event Report: MAKO SURGICAL CORP. IMPACTOR-ONLAY INSERT; PROSTHESIS, KNEE PATELLOFEMOROTIBIAL, PARTIAL, SEMI-CONSTRAINED, CEMENTED, POLYM

Model Number 160405

Device Problems Break (1069); Fracture (1260)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 09/20/2019

Event Type  malfunction  

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.Device not returned.

Event Description

Impactor chipped upon impacting poly in.Case type: pka.Patient was under anesthesia.

Manufacturer Narrative

H1: type of reportable event initial reported as serious injury in error, corrected to malfunction.An event regarding crack/fracture involving a mako impactor was reported.The event was not confirmed.Method & results: device evaluation and results: not performed as product was not returned.Clinician review: no medical records were received for review with a clinical consultant.Device history review: all devices were manufactured and accepted into final stock with no relevant reported discrepancies.Complaint history review: there have been no other similar events for the reported lot.Conclusion no further investigation for this event is possible at this time as no devices nor sufficient information was received by stryker orthopaedics.If devices and additional information become available to indicate further evaluation is warranted, this record will be reopened.

Event Description

Impactor chipped upon impacting poly in.Case type: pka.Patient was under anesthesia.

• Brand Name: IMPACTOR-ONLAY INSERT
• Type of Device: PROSTHESIS, KNEE PATELLOFEMOROTIBIAL, PARTIAL, SEMI-CONSTRAINED, CEMENTED, POLYM
• Manufacturer (Section D): MAKO SURGICAL CORP.; 2555 davie road; fort lauderdale FL 33317
• MDR Report Key: 9202288
• MDR Text Key: 162897335
• Report Number: 3005985723-2019-00744
• Device Sequence Number: 1
• Product Code: NPJ
• UDI-Device Identifier: 00848486003203
• UDI-Public: 00848486003203
• Combination Product (y/n): N
• PMA/PMN Number: K090763
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Type of Report: Initial,Followup
• Report Date: 01/28/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/17/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 11/30/2020
• Device Model Number: 160405
• Device Catalogue Number: 160405
• Device Lot Number: 12500815
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 12/30/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other