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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BIOMET UK LTD. TAPERLOC FEMORAL STEM PROSTHESIS, HIP

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BIOMET UK LTD. TAPERLOC FEMORAL STEM PROSTHESIS, HIP Back to Search Results
Model Number N/A
Device Problem Component Missing
Event Date 05/23/2017
Event Type  Injury  
Manufacturer Narrative

(b)(4). Report source, foreign ¿ event occurred in (b)(6). Customer has indicated that the product is in process of being returned to zimmer biomet for investigation. Once the investigation has been completed, a follow-up mdr will be submitted.

 
Event Description

It was reported that during a hip procedure, it was found the kit of custom devices was missing components. The surgeon had to use alternative devices which resulted in the stem not seating properly. The surgeon attempted to seat the stem further in the bone with a head impactor, causing the patient's femur to fracture.

 
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Brand NameTAPERLOC FEMORAL STEM
Type of DevicePROSTHESIS, HIP
Manufacturer (Section D)
BIOMET UK LTD.
waterton industrial estates
bridgend CF31 3XA
UK  CF31 3XA
Manufacturer (Section G)
BIOMET UK LTD.
waterton industrial estates
bridgend CF31 3XA
UK  CF31 3XA
Manufacturer Contact
christina arnt
56 e. bell dr.
warsaw , IN 46582
5745273773
MDR Report Key6653863
Report Number3002806535-2017-00521
Device Sequence Number1
Product CodeLPH
Report Source Manufacturer
Source Type FOREIGN,USER FACILITY
Reporter Occupation
Type of Report Initial,Followup
Report Date 04/20/2018
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received06/20/2017
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? Yes
Device Operator
Device MODEL NumberN/A
Device Catalogue Number21-103205
Device LOT Number668420
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 Received04/20/2018
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
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: 06/20/2017 Patient Sequence Number: 1
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