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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ZIMMER BIOMET, INC. FEMORAL STEM 12/14 NECK TAPER PROSTHESIS, HIP

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ZIMMER BIOMET, INC. FEMORAL STEM 12/14 NECK TAPER PROSTHESIS, HIP Back to Search Results
Model Number N/A
Device Problems Positioning Failure; Difficult to Insert; Difficult To Position; Defective Device
Event Date 05/02/2018
Event Type  Injury  
Manufacturer Narrative

(b)(4). 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 arthroplasty, the stem sat proud of where broach sat during broaching. The stem was removed and the femur was prepared for a larger size stem. A new stem was implanted successfully. Attempts to obtain additional information have been made; however, no more is available at this time.

 
Manufacturer Narrative

The following report is being submitted to relay additional information received. Udi: (b)(4) the complaint cannot be confirmed as no medical records or device was not returned. The device history records identified no deviations or anomalies that could contribute to the reported event. A definitive root cause cannot be determined with the information provided. A summary of the investigation has been sent to the complainant. If any further information is found which would change or alter any conclusions or information, a supplemental report will be filed accordingly. Zimmer biomet will continue to monitor for trends.

 
Event Description

No additional information is available to report at this time.

 
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Brand NameFEMORAL STEM 12/14 NECK TAPER
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 Key7575066
Report Number0001822565-2018-03048
Device Sequence Number1
Product CodeLZO
Report Source Manufacturer
Source Type COMPANY REPRESENTATIVE,DISTRI
Reporter Occupation
Type of Report Initial,Followup
Report Date 01/30/2019
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received06/06/2018
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? Yes
Device Operator
Device MODEL NumberN/A
Device Catalogue Number00771101320
Device LOT Number63825872
OTHER Device ID NumberN/A
Was Device Available For Evaluation? No
Is The Reporter A Health Professional? Yes
Was the Report Sent to FDA? No
Event Location No Information
Date Manufacturer Received01/30/2019
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
Date Device Manufactured03/26/2018
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: 06/06/2018 Patient Sequence Number: 1
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