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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ZIMMER BIOMET, INC. UNKNOWN SHELL PROSTHESIS, HIP

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ZIMMER BIOMET, INC. UNKNOWN SHELL PROSTHESIS, HIP Back to Search Results
Model Number N/A
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Tissue Damage (2104); Blood Loss (2597); Osteopenia/ Osteoporosis (2651); Patient Problem/Medical Problem (2688)
Event Date 03/30/2017
Event Type  Injury  
Manufacturer Narrative
Concomitant medical products: item #: unknown unknown head lot #: unknown, 00786201350 lot 07886766 stem 13 eo. 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. Multiple mdr reports were filed for this event, please see associated reports: 0001822565 - 2019 - 04512stem, 0001822565 - 2019 - 04514head.
 
Event Description
It was reported that an initial right total hip arthroplasty performed and subsequently underwent revision of the head and liner due to complications from trunnionosis seven years later. The patient then underwent a second revision due to pain, wound complications, and radiolucency with apparent acetabular screw fracture on x-ray. After the second revision, the patient fell due to unknown reasons and suffered an acetabular protrusion. A third revision was performed a month after the second revision during which all components were removed and a girdlestone procedure was performed. Attempts were made to obtain additional information; however, none was available.
 
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Brand NameUNKNOWN SHELL
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 Key9212543
MDR Text Key163150505
Report Number0001822565-2019-04515
Device Sequence Number1
Product Code KWA
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
N/A
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 02/12/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received10/20/2019
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Model 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 Received02/03/2020
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
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: 10/20/2019 Patient Sequence Number: 1
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