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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ZIMMER BIOMET, INC. E1 RINGLOC ACETABULAR LINER PROSTHESIS, HIP

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ZIMMER BIOMET, INC. E1 RINGLOC ACETABULAR LINER PROSTHESIS, HIP Back to Search Results
Model Number N/A
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problem Unspecified Infection (1930)
Event Date 11/13/2015
Event Type  Injury  
Manufacturer Narrative
(b)(4). Age: (b)(6). Concomitant medical products: 14-103652 987570 univ 2-hole shl 52mm lnr sz 23, 51-106110 3383479 tprlc 133 mp type1 pps so 11. 0, 650-1158 3262651 delta cer fem hd 28/0mm t1. Report source: (b)(6). Customer has indicated that the product will not be returned to zimmer biomet for investigation, due to device remains implanted. 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: 0001825034 - 2019 - 04857, 0001825034 - 2019 - 04860.
 
Event Description
It was noted the patient underwent a primary left total hip arthroplasty. Subsequently, the patient experienced an infection and underwent incision and drainage approximately two weeks post implantation. Attempts have been made and additional information on the reported event is unavailable.
 
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Brand NameE1 RINGLOC ACETABULAR LINER
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 Key9248018
MDR Text Key164138058
Report Number0001825034-2019-04858
Device Sequence Number1
Product Code OIY
Combination Product (y/n)N
Reporter Country CodeKS
PMA/PMN Number
K100048
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Reporter Occupation
Type of Report Initial,Followup
Report Date 02/28/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received10/28/2019
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Expiration Date01/31/2018
Device Model NumberN/A
Device Catalogue NumberEP-105883
Device Lot Number166560
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 Received02/27/2020
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured01/31/2013
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: 10/28/2019 Patient Sequence Number: 1
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