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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ZIMMER BIOMET, INC. ECHO POR FEM RED LAT NC 14X150 PROSTHESIS, HIP

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ZIMMER BIOMET, INC. ECHO POR FEM RED LAT NC 14X150 PROSTHESIS, HIP Back to Search Results
Model Number N/A
Device Problem Difficult To Position
Event Date 11/21/2016
Event Type  Injury  
Manufacturer Narrative

(b)(4). Concomitant medical products: 650-1065 cer option type 1 tpr sleve -3 640510, 192514 echo por fem red lat nc 14x150 085260, ep-200156 act artic e1 hip brg 28x50mm s56 dia28 049150, 650-1055 cer bioloxd option hd 28mm 017250, us157856 m2a-magnum pf cup 56odx50id 475950. Reported event was unable to be confirmed due to limited information received from the customer. Dhr was reviewed and nodiscrepancies were found. Review of the complaint history determined that no further action is required. The root cause can likely be attributed to the non compatibility of the components used in the procedure,however definitive root cause cannot be determined. If any further information is found which would change or alter any conclusions or information, a supplemental will be filed accordingly. Zimmer biomet will continue to monitor for trends.

 
Event Description

During the procedure there was difficulty impacting the active articulation construct onto the stem trunnion. The construct was seated inside the cup and the stem was aligned and placed inside the taper to complete the procedure. A forty-five minute delay resulted from the event.

 
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Brand NameECHO POR FEM RED LAT NC 14X150
Type of DevicePROSTHESIS, HIP
Manufacturer (Section D)
ZIMMER BIOMET, INC.
56 e. bell drive
warsaw IN 46582
Manufacturer (Section G)
ZIMMER BIOMET, INC.
56 e. bell drive
warsaw IN 46582
Manufacturer Contact
christina arnt
56 e. bell dr.
warsaw , IN 46582
5745273773
MDR Report Key7391696
Report Number0001825034-2018-02330
Device Sequence Number1
Product CodeLPH
Report Source Manufacturer
Source Type DISTRIBUTOR,HEALTH PROFESSION
Reporter Occupation
Type of Report Initial
Report Date 04/02/2018
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received04/03/2018
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? Yes
Device Operator HEALTH PROFESSIONAL
Device MODEL NumberN/A
Device Catalogue Number192514
Device LOT Number085260
OTHER Device ID NumberN/A
Was Device Available For Evaluation? No
Is The Reporter A Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received04/02/2018
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
Date Device Manufactured05/01/2014
Is The Device Single Use? Yes
Is this a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Removal/Correction NumberN/A

Patient TREATMENT DATA
Date Received: 04/03/2018 Patient Sequence Number: 1
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