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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ZIMMER BIOMET, INC. E-POLY 36MM +3 MAXROM LNR SZ23 HIP PROSTHESIS

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ZIMMER BIOMET, INC. E-POLY 36MM +3 MAXROM LNR SZ23 HIP PROSTHESIS Back to Search Results
Model Number N/A
Device Problems Fracture (1260); Noise, Audible (3273)
Patient Problem Local Reaction (2035)
Event Date 05/21/2019
Event Type  Injury  
Manufacturer Narrative
(b)(4). Concomitant medical products: item #11-363662 cocr mod hd std lot #915940, item #11-106052 r/b rloc lhole shl lot #805900, item # 51-104140 tprlc 133 t1 pps lot #3391418. Customer has indicated that the product is in process of being returned to zimmer biomet for investigation. 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: 0001825034-2019-02493, 0001825034-2019-02494.
 
Event Description
It was reported that a patient underwent an initial left hip procedure. Subsequently, approximately four months post op the patient was revised due to metallosis and poly liner fracture. Additional information was requested however, none was available.
 
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Brand NameE-POLY 36MM +3 MAXROM LNR SZ23
Type of DeviceHIP PROSTHESIS
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 Key8682334
MDR Text Key147441141
Report Number0001825034-2019-02495
Device Sequence Number1
Product Code MAY
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K090103
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 08/27/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received06/10/2019
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date01/31/2020
Device Model NumberN/A
Device Catalogue NumberEP-108223
Device Lot Number841250
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer06/10/2019
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? No
Event Location No Information
Date Manufacturer Received08/26/2019
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured01/06/2015
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: 06/10/2019 Patient Sequence Number: 1
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