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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ZIMMER BIOMET, INC. HFN A/R SCREW 105MM PROSTHESIS, TRAUMA

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ZIMMER BIOMET, INC. HFN A/R SCREW 105MM PROSTHESIS, TRAUMA Back to Search Results
Catalog Number 814501105
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Fall (1848); Patient Problem/Medical Problem (2688)
Event Date 05/26/2020
Event Type  Injury  
Manufacturer Narrative
(b)(4). Multiple mdr reports were filed for this event, please see associated reports: 0001825034-2020-02358, 0001825034-2020-02359, 0001825034-2020-02360. Concomitant medical products: part#: 814509180, lot#: 661770. Part#: 814550038, lot#: m18817a. Part#: 814510115, lot#: vk1121315c. Part#: 903003004, lot#: unk. Part#: 211201505, lot#: unk. Part#: 211201405, lot#: unk. Customer has indicated that the product will not be returned to zimmer biomet for investigation, as it is not available to be returned per hospital policy. The investigation is in process. Once the investigation has been completed, a follow-up mdr will be submitted. 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
It was reported that the initial surgery was approximately two (2) months ago. At the three (3) week check-up, surgeon was satisfied with follow up films. Approximately one (1) month post-implantation, obese patient fell and apparently "hobbled" on it for five (5) days before being removed. All implants were intact. Surgeon implanted a total hip because the lag screw penetrated through the femoral head (ie. Cut out).
 
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Brand NameHFN A/R SCREW 105MM
Type of DevicePROSTHESIS, TRAUMA
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 Key10153508
MDR Text Key197744713
Report Number0001825034-2020-02361
Device Sequence Number1
Product Code HSB
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K100238
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type distributor,health profession
Reporter Occupation
Type of Report Initial,Followup
Report Date 10/13/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received06/15/2020
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Catalogue Number814501105
Device Lot NumberTH1211305C
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 Received10/12/2020
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured04/18/2018
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Invalid Data
Removal/Correction NumberNI

Patient Treatment Data
Date Received: 06/15/2020 Patient Sequence Number: 1
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