Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links
  • 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. UNKNOWN LINER; 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. UNKNOWN LINER; PROSTHESIS, HIP Back to Search Results
Model Number N/A
Device Problem Positioning Failure (1158)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 11/08/2020
Event Type  Injury  
Manufacturer Narrative
(b)(4).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 - 2020 - 04048.
 
Event Description
It was reported during an initial tha, there was something wrong with the ring in the ringloc make it so the implant would not seat properly.Sales rep reported during an initial tha, something was wrong with the ring on the ring loc implant causing it not to seat well.The surgery was completed with endo liner.No adverse event occurred.Attempts have been made and no further information has been provided.
 
Event Description
Upon reassessment of the reported event, it has been determined that this device is a sub-component of item 11-165222 which has already been reported.The initial report was forwarded in error and should be voided.
 
Manufacturer Narrative
Upon reassessment of the reported event, it has been determined that this device is a sub-component of item 11-165222 which has already been reported.The initial report was forwarded in error and should be voided.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand Name
UNKNOWN LINER
Type of Device
PROSTHESIS, HIP
Manufacturer (Section D)
ZIMMER BIOMET, INC.
56 e. bell drive
warsaw IN 46582
MDR Report Key10929353
MDR Text Key219510573
Report Number0001825034-2020-04235
Device Sequence Number1
Product Code KWY
Combination Product (y/n)N
PMA/PMN Number
NI
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type distributor,health profession
Type of Report Initial,Followup
Report Date 01/04/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received12/01/2020
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Model NumberN/A
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer11/25/2020
Was the Report Sent to FDA? No
Date Manufacturer Received12/28/2020
Is This a Reprocessed and Reused Single-Use Device? No
Removal/Correction NumberN/A
Patient Sequence Number1
Treatment
11-165222 RINGLOC CUP 794650
-
-