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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ZIMMER BIOMET, INC. METAL PROVISIONAL PROXIMAL BODY ORTHOPEDIC MANUAL SURGICAL INSTRUMENT

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ZIMMER BIOMET, INC. METAL PROVISIONAL PROXIMAL BODY ORTHOPEDIC MANUAL SURGICAL INSTRUMENT Back to Search Results
Model Number N/A
Device Problems Fracture; Difficult or Delayed Separation
Event Date 12/07/2019
Event Type  Malfunction  
Manufacturer Narrative

(b)(4). Concomitant medical products: zimmer stem cat#00998201918 lot#63062926, zimmer femoral body cat#00999601835 lot#63855887, zimmer head cat#00801802801 lot#63981285, zimmer stem cat#00998201918 lot#63999084, unknown cone body cat#ni lot#ni. Report source: foreign country: (b)(6). The device will not be returned for analysis; however, an investigation of the reported event is in progress. Once the investigation is completed, a supplemental medwatch 3500a will be submitted. Multiple mdr reports were filed for this event, please see associated reports: 0001822565 - 2019 - 05428.

 
Event Description

It was reported during a hip revision surgery, a zmr stem was put into the patient. The trial cone body was checked for range of motion and when the surgeon tried to get the cone body off, the screw mechanism snapped and cone body was unable to be removed from stem. Cone body and definite stem came out together and body was removed and surgeon didn't try as it would damage the junction. Another stem was put in to complete the procedure. Attempts have been made and additional information on the reported event is unavailable at this time.

 
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Brand NameMETAL PROVISIONAL PROXIMAL BODY
Type of DeviceORTHOPEDIC MANUAL SURGICAL INSTRUMENT
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 Key9520645
Report Number0001822565-2019-05429
Device Sequence Number1
Product CodeLZO
Report Source Manufacturer
Source Type COMPANY REPRESENTATIVE,FOREIG
Reporter Occupation
Type of Report Initial,Followup
Report Date 04/29/2020
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received12/26/2019
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? Yes
Device Operator HEALTH PROFESSIONAL
Device MODEL NumberN/A
Device Catalogue Number00999604035
Device LOT Number62807355
Was Device Available For Evaluation? Device Returned To Manufacturer
Date Returned to Manufacturer01/13/2020
Is The Reporter A Health Professional? Yes
Was the Report Sent to FDA? No
Event Location No Information
Date Manufacturer Received04/29/2020
Was Device Evaluated By Manufacturer? Yes
Date Device Manufactured08/16/2014
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: 12/26/2019 Patient Sequence Number: 1
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