• Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BIOMET ORTHOPEDICS RINGLOC+ REPLACEMENT RING SZ21 PROSTHESIS, HIP

  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 

BIOMET ORTHOPEDICS RINGLOC+ REPLACEMENT RING SZ21 PROSTHESIS, HIP Back to Search Results
Model Number N/A
Device Problem Bent (1059)
Patient Problem No Information (3190)
Event Date 07/26/2017
Event Type  Malfunction  
Manufacturer Narrative

(b)(6). The device has not been returned for evaluation at this time. The investigation is in process. Once the investigation has been completed, a follow-up mdr will be submitted. Not returned to manufacturer.

 
Event Description

It was reported two locking rings were damaged intraoperatively. No complications or delays reported. No further information made available at this time.

 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand NameRINGLOC+ REPLACEMENT RING SZ21
Type of DevicePROSTHESIS, HIP
Manufacturer (Section D)
BIOMET ORTHOPEDICS
56 e. bell drive
warsaw IN 46582
Manufacturer (Section G)
BIOMET ORTHOPEDICS
56 e. bell drive
warsaw IN 46582
Manufacturer Contact
christina arnt
56 e. bell dr.
warsaw, IN 46582
5745273773
MDR Report Key6819812
MDR Text Key83747149
Report Number0001825034-2017-06204
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 01/09/2018
1 Device Was Involved in the Event
0 PatientS WERE Involved in the Event:
Date FDA Received08/25/2017
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 Number684850
OTHER Device ID Number(01) 0 0880304 45517 7
Was Device Available For Evaluation? No
Is The Reporter A Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received01/08/2018
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
Date Device Manufactured04/04/2016
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

-
-