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

MAUDE Adverse Event Report: ZIMMER BIOMET, INC. RINGLOC BI-POLAR 28X54MM 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
 

ZIMMER BIOMET, INC. RINGLOC BI-POLAR 28X54MM PROSTHESIS, HIP Back to Search Results
Model Number N/A
Device Problem Component Missing (2306)
Patient Problem No Code Available (3191)
Event Date 08/31/2018
Event Type  Injury  
Manufacturer Narrative
(b)(4). Report source (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 during an operation, the cup was opened and found that the ring was missing. There was a delay in the surgery of over 30 minutes while a new product was received and opened. Attempts have been made and additional information on the reported event is unavailable at this time.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand NameRINGLOC BI-POLAR 28X54MM
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 Key7980566
MDR Text Key124187731
Report Number0001825034-2018-09820
Device Sequence Number1
Product Code KWY
Combination Product (y/n)N
Reporter Country CodeKS
PMA/PMN Number
PK833175
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Reporter Occupation Other Health Care Professional
Type of Report Initial,Followup
Report Date 06/11/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received10/18/2018
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date10/31/2019
Device Model NumberN/A
Device Catalogue Number11-165232
Device Lot Number141940
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer11/19/2018
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? No
Event Location No Information
Date Manufacturer Received06/10/2019
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured10/27/2014
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

Patient Treatment Data
Date Received: 10/18/2018 Patient Sequence Number: 1
-
-