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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BIOMET ORTHOPEDICS TAPER ADAPTOR REMOVAL ASSEMBLY INSTRUMENT, HIP

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BIOMET ORTHOPEDICS TAPER ADAPTOR REMOVAL ASSEMBLY INSTRUMENT, HIP Back to Search Results
Model Number N/A
Device Problem Device Operates Differently Than Expected
Event Date 05/30/2017
Event Type  Injury  
Manufacturer Narrative

(b)(4). The device has not been returned for evaluation at this time. The investigation is in process. Once the investigation has been completed, a follow-up mdr will be submitted.

 
Event Description

It was reported that during a hip revision procedure, the taper adapter tool did not function as intended. This resulted in femoral stem removal and a 2. 5 hour delay in procedure.

 
Manufacturer Narrative

This follow-up report is being submitted to relay additional information. Reported event was unable to be confirmed due to limited information received from the customer. Photo of the instrument was provided however no evaluation can be performed using the provided photo. Dhr was reviewed and no discrepancies relevant to the reported event were found. Review of the complaint history determined that no further action is required. Root cause was unable to be determined as the necessary information to adequately investigate the reported event was not provided. 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.

 
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Brand NameTAPER ADAPTOR REMOVAL ASSEMBLY
Type of DeviceINSTRUMENT, HIP
Manufacturer (Section D)
BIOMET ORTHOPEDICS
56 e. bell drive
warsaw IN 46582
Manufacturer (Section G)
BIOMET ORTHOPEDICS
56 e. bell drive
warsaw IN 46582
Manufacturer Contact
christina arnt
56 e. bell dr.
warsaw , IN 46582
5745273773
MDR Report Key6800055
Report Number0001825034-2017-05963
Device Sequence Number1
Product CodeLZO
Report Source Manufacturer
Source Type DISTRIBUTOR,HEALTH PROFESSION
Reporter Occupation
Type of Report Initial,Followup
Report Date 02/14/2018
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received08/17/2017
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? Yes
Device Operator
Device MODEL NumberN/A
Device Catalogue Number110005232
Device LOT Number056430
OTHER Device ID Number(01)00880304537392
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 Received02/14/2018
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
Date Device Manufactured02/15/2017
Is The Device Single Use? No
Is this a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Reuse
Removal/Correction NumberN/A

Patient TREATMENT DATA
Date Received: 08/17/2017 Patient Sequence Number: 1
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