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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ZIMMER BIOMET, INC. G7 HI-WALL E1 LINER 36MM F PROSTHESIS, HIP

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ZIMMER BIOMET, INC. G7 HI-WALL E1 LINER 36MM F PROSTHESIS, HIP Back to Search Results
Model Number N/A
Device Problem Noise, Audible (3273)
Patient Problem No Information (3190)
Event Type  Malfunction  
Manufacturer Narrative

(b)(4). Implant date- 2017 pps ltd acet shell 54f pn (b)(4). Ln6033366. Cls femoral stem (b)(4). Ln 2905069. Biolox delta femoral head (b)(4) ln 2904670. Reporting source- (b)(6). Customer has indicated that the product will not be returned to zimmer biomet for investigation. The investigation is in process. Once the investigation has been completed, a follow-up mdr will be submitted.

 
Event Description

It was reported that a patient is experiencing a noisy implant approximately a year after surgery. Attempts have been made and additional information on the reported event is unavailable at this time. No further information is available.

 
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Brand NameG7 HI-WALL E1 LINER 36MM F
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 Key8235770
MDR Text Key132852199
Report Number0001825034-2019-00096
Device Sequence Number1
Product Code LZO
Combination Product (Y/N)N
Reporter Country CodeIT
PMA/PMN NumberK121874
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type DISTRIBUTOR,FOREIGN,HEALTH PR
Reporter Occupation
Type of Report Initial,Followup
Report Date 07/18/2019
1 Device Was Involved in the Event
0 PatientS WERE Involved in the Event:
Date FDA Received01/10/2019
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator HEALTH PROFESSIONAL
Device MODEL NumberN/A
Device Catalogue Number010000936
Device LOT Number6099125
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 Received07/02/2019
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
Date Device Manufactured05/01/2012
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

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