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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ZIMMER BIOMET, INC. EPOLY 32MM RLC LNR +5 SZ22 PROSTHESIS, HIP

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ZIMMER BIOMET, INC. EPOLY 32MM RLC LNR +5 SZ22 PROSTHESIS, HIP Back to Search Results
Model Number N/A
Device Problems Positioning Failure (1158); Difficult to Insert (1316); Off-Label Use (1494)
Patient Problems No Known Impact Or Consequence To Patient (2692); No Information (3190)
Event Date 03/27/2020
Event Type  malfunction  
Manufacturer Narrative
(b)(4). (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.
 
Event Description
It was reported that the patient had an initial hip replacement on an unknown date. The patient was then revised for unknown reasons and the liner was replaced. During the procedure, the first liner did not fit into the shell. The surgery was finished with backup liner. Attempts have been made and no further information has been provided.
 
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Brand NameEPOLY 32MM RLC LNR +5 SZ22
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 Key9996301
MDR Text Key188847800
Report Number0001825034-2020-01743
Device Sequence Number1
Product Code OIY
Combination Product (y/n)N
Reporter Country CodeJA
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,Followup
Report Date 07/20/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received04/24/2020
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date09/21/2020
Device Model NumberN/A
Device Catalogue NumberEP-155232
Device Lot Number435460
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer06/29/2020
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? No
Event Location No Information
Date Manufacturer Received07/20/2020
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured09/21/2015
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: 04/24/2020 Patient Sequence Number: 1
Treatment
UNKNOWN CUP, UNKNOWN ITEM AND UNKNOWN LOT
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