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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ZIMMER BIOMET, INC. RINGLOC+ REPLACEMENT RING SZ21 PROTHESIS, HIP

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ZIMMER BIOMET, INC. RINGLOC+ REPLACEMENT RING SZ21 PROTHESIS, HIP Back to Search Results
Model Number N/A
Device Problems Bent (1059); Device Damaged by Another Device (2915)
Patient Problem No Information (3190)
Event Date 03/21/2018
Event Type  Malfunction  
Manufacturer Narrative

(b)(4). Concomitant products: ep-115393, e1 44-36 std hmrl brng, 963040; ep-115393, e1 44-36 std hmrl brng, 654320. Product has been received by zimmer biomet and 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 - 2018 - 02892, 0001825034 - 2018 - 02893.

 
Event Description

It was reported that the first humeral bearing was damaged during a back table assembly into the humeral tray. A new ring was put into the humeral tray. The second humeral bearing was also damaged during back table assembly. Attempts have been made and additional information on the reported event is unavailable.

 
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Brand NameRINGLOC+ REPLACEMENT RING SZ21
Type of DevicePROTHESIS, 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 Key7467734
MDR Text Key106736406
Report Number0001825034-2018-02891
Device Sequence Number1
Product Code LPH
Combination Product (Y/N)N
Reporter Country CodeUS
PMA/PMN NumberPK070369
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 07/03/2018
1 Device Was Involved in the Event
0 PatientS WERE Involved in the Event:
Date FDA Received04/27/2018
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator
Device MODEL NumberN/A
Device Catalogue Number106021
Device LOT Number039870
OTHER Device ID Number(01) 00880304355177
Was Device Available For Evaluation? Device Returned To Manufacturer
Date Returned to Manufacturer04/05/2018
Is The Reporter A Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received07/02/2018
Was Device Evaluated By Manufacturer? Yes
Date Device Manufactured04/13/2017
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

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