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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MAKO SURGICAL CORP. INSERTER- STRAIGHT SHELL HIP PROSTHESIS, SEMI-CONSTRAINED, CEMENTED, METAL/POLYMER, + ADDITIVE, POROUS, U

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MAKO SURGICAL CORP. INSERTER- STRAIGHT SHELL HIP PROSTHESIS, SEMI-CONSTRAINED, CEMENTED, METAL/POLYMER, + ADDITIVE, POROUS, U Back to Search Results
Catalog Number 112710
Device Problems Break; Device Operates Differently Than Expected; Material Integrity Problem
Event Date 10/19/2015
Event Type  Malfunction  
Manufacturer Narrative

A supplemental report will be submitted upon completion of the investigation.

 
Event Description

The 36mm poly-liner impactor head and the pst shell inserter straight would not thread together. Left hip.

 
Manufacturer Narrative

An event regarding damaged threads involving a mako inserter was reported. The event was confirmed. Method & results: -device evaluation and results: visual inspection confirmed the reported event. -medical records received and evaluation: no patient medical records were available for review. -device history review indicated the devices accepted into final stock from the reported lot were free from discrepancies -complaint history review: there has been one other event for the lot referenced. Conclusions: the investigation determined the likely root cause of the damage was due to cross threading made apparent by the consistency of damage along the threads. There is no indication at this time that the design, materials, or manufacturing of the subject device contributed to the event.

 
Event Description

The 36mm poly-liner impactor head and the pst shell inserter straight would not thread together. Left hip.

 
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Brand NameINSERTER- STRAIGHT SHELL
Type of DeviceHIP PROSTHESIS, SEMI-CONSTRAINED, CEMENTED, METAL/POLYMER, + ADDITIVE, POROUS, U
Manufacturer (Section D)
MAKO SURGICAL CORP.
2555 davie road
fort lauderdale FL 33317
Manufacturer (Section G)
MAKO SURGICAL CORP.
2555 davie road
fort lauderdale FL 33317
Manufacturer Contact
keyla navedo
325 corporate drive
mahwah , NJ 07430
2018315000
MDR Report Key5226018
Report Number3005985723-2015-00244
Device Sequence Number1
Product CodeLZO
Report Source Manufacturer
Source Type HEALTH PROFESSIONAL,OTHER
Reporter Occupation
Type of Report Initial,Followup
Report Date 10/19/2015
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received11/16/2015
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator HEALTH PROFESSIONAL
Device EXPIRATION Date08/30/2018
Device Catalogue Number112710
Device LOT Number120087
Was Device Available For Evaluation? Device Returned To Manufacturer
Date Returned to Manufacturer01/14/2016
Is The Reporter A Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received02/02/2016
Was Device Evaluated By Manufacturer? Yes
Date Device Manufactured08/27/2013
Is The Device Single Use? No
Is this a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Reuse

Patient TREATMENT DATA
Date Received: 11/16/2015 Patient Sequence Number: 1
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