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U.S. Department of Health and Human Services

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

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ZIMMER BIOMET, INC. E-POLY 40MM +3 HIWALL LNR SZ24 PROSTHESIS, HIP Back to Search Results
Model Number N/A
Device Problems Fracture (1260); Naturally Worn (2988)
Patient Problems Unspecified Infection (1930); Necrosis (1971); Pain (1994); Sepsis (2067); Swelling (2091); Hypovolemia (2243); Blood Loss (2597)
Event Date 03/12/2018
Event Type  Injury  
Manufacturer Narrative
(b)(4). Concomitant medical products: 00801804002 62358028 12/14 cocr femoral head 40mm +0, 00771300900 62309332 m/l taper kinectiv stem size 9, 00784803201 62198159 kinectiv modular neck g2, 103531 939930 ti low profile screw 6. 5x20mm, 106054 884870 ran/bur rnglc shl 54mm sz 24, 103531 405190 ti low profile screw 6. 5x20mm. 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. Multiple mdr reports were filed for this event, please see associated reports: 0002648920 - 2020 - 00025 head, 0001822565 - 2020 - 00152 neck, 0001822565 - 2020 - 00961 stem, 0001825034 - 2020 - 01204 shell.
 
Event Description
It was reported by patients¿ legal counsel that the patient underwent a right hip revision procedure approximately 5 years post-implantation due to metallosis, tissue damage, periprosthetic fracture and infection, polyethylene failure. All devices removed due to infection. Spacers implanted. Attempts were made to obtain additional information; however, none was available.
 
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Brand NameE-POLY 40MM +3 HIWALL 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 Key9859736
MDR Text Key184461320
Report Number0001825034-2020-01203
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 consumer,distributor,health p
Reporter Occupation
Type of Report Initial,Followup,Followup
Report Date 06/19/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received03/20/2020
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date10/31/2018
Device Model NumberN/A
Device Catalogue NumberEP-108524
Device Lot Number921590
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 Received06/18/2020
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured10/28/2013
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: 03/20/2020 Patient Sequence Number: 1
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