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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ZIMMER BIOMET, INC. E-POLY 40MM +3 MAXROM LNR SZ24 PROSTHESIS, HIP

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ZIMMER BIOMET, INC. E-POLY 40MM +3 MAXROM LNR SZ24 PROSTHESIS, HIP Back to Search Results
Model Number N/A
Device Problem Device Dislodged or Dislocated (2923)
Patient Problem Joint Dislocation (2374)
Event Date 06/27/2018
Event Type  Injury  
Manufacturer Narrative
(b)(4). Concomitant medical product(s: 650-1064 cer option type 1 tpr sleve -6 2914167; 650-1058 cer bioloxd option hd 40mm 2904573; pt-116056 regen/rnglc+ ltd 56mm sz 24 240160; 51-108080 tprlc 133 mp t1 pps so 8x101mm 6006745. Customer has indicated that the product will not be returned to zimmer biomet for investigation. The product location is unknown. The investigation is in process. Once the investigation has been completed, a follow-up mdr will be submitted.
 
Event Description
It was reported that patient underwent right total hip arthroplasty and subsequently was revised three months later due dislocation. The head and liner components were removed and replaced. Attempts were made to obtain additional information; however, none was available.
 
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Brand NameE-POLY 40MM +3 MAXROM LNR SZ24
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 Key9608257
MDR Text Key187617213
Report Number0001825034-2020-00290
Device Sequence Number1
Product Code OIY
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K100048
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 05/05/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received01/20/2020
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date02/08/2022
Device Model NumberN/A
Device Catalogue NumberEP-108424
Device Lot Number538330
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 Received04/30/2020
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured02/08/2017
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: 01/20/2020 Patient Sequence Number: 1
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