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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ZIMMER BIOMET, INC. TAPERLOC POR LAT FMRL 11X142 PROSTHESIS HIP

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ZIMMER BIOMET, INC. TAPERLOC POR LAT FMRL 11X142 PROSTHESIS HIP Back to Search Results
Catalog Number 11-103205
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Pain (1994); Tissue Damage (2104); Reaction (2414)
Event Date 08/06/2020
Event Type  Injury  
Manufacturer Narrative
(b)(4). Customer has indicated that the product will not be returned to zimmer biomet for investigation, as product location is unknown. The investigation is in process. Once the investigation has been completed, a follow-up mdr will be submitted. Concomitant medical devices: part# us157852/ m2a cup/ lot # 372780; part#157446/ head/ lot# 920470; part# 139256/ m2a taper/ lot # 221880. Multiple mdr reports were filed for this event, please see associated reports: 0001825034 -2021 -00290, 0001825034 -2020 -04090, 0001825034 -2020 -04091.
 
Event Description
It was reported that the patient underwent a left hip revision surgery approximately 10 years post implantation due to pain, metallosis, and tissue damage. Attempts have been made and additional information is not available at this time.
 
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Brand NameTAPERLOC POR LAT FMRL 11X142
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 Key11252270
MDR Text Key229429320
Report Number0001825034-2021-00289
Device Sequence Number1
Product Code MEH
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K830313
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type consumer,distributor,health p
Reporter Occupation
Type of Report Initial,Followup
Report Date 02/03/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received01/29/2021
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date06/30/2019
Device Catalogue Number11-103205
Device Lot Number925960
Was Device Available for Evaluation? No Answer Provided
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? No
Event Location No Information
Date Manufacturer Received02/02/2021
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured06/30/2009
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Invalid Data

Patient Treatment Data
Date Received: 01/29/2021 Patient Sequence Number: 1
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