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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ZIMMER BIOMET, INC. EPOLY 36MM +5 RGLC LNR HW SZ23 Z23 PROSTHESIS, HIP

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ZIMMER BIOMET, INC. EPOLY 36MM +5 RGLC LNR HW SZ23 Z23 PROSTHESIS, HIP Back to Search Results
Model Number N/A
Device Problems Fracture (1260); Device Dislodged or Dislocated (2923)
Patient Problems Joint Dislocation (2374); No Code Available (3191)
Event Date 01/10/2020
Event Type  Injury  
Manufacturer Narrative
(b)(4). Concomitant medical products: catalog#: 11-363664 36mm cocr mod hd +6mm lot#: 271810, catalog#: ni ringloc cup 58mm finned lot#: 450080. Report source: foreign: (b)(6). 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: 0001825034-2020-00405.
 
Event Description
It was reported that the patient underwent a revision procedure due to dislocation and fracture of the liner. Attempts have been made and additional information on the reported event is unavailable at this time.
 
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Brand NameEPOLY 36MM +5 RGLC LNR HW SZ23 Z23
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 Key9632687
MDR Text Key176550692
Report Number0001825034-2020-00404
Device Sequence Number1
Product Code OIY
Combination Product (y/n)N
Reporter Country CodeCA
PMA/PMN Number
K100048
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type distributor,foreign,health pr
Reporter Occupation
Type of Report Initial,Followup
Report Date 05/08/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received01/27/2020
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Model NumberN/A
Device Catalogue NumberEP-105790
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer02/21/2020
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? No
Event Location No Information
Date Manufacturer Received05/05/2020
Was Device Evaluated by Manufacturer? Yes
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: 01/27/2020 Patient Sequence Number: 1
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