• 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. PATELLA REAMER INSETTING GUIDE WITH COATING 26 MM DIAMETER 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. PATELLA REAMER INSETTING GUIDE WITH COATING 26 MM DIAMETER PROSTHESIS, HIP Back to Search Results
Model Number N/A
Device Problem Difficult to Insert
Event Date 11/08/2018
Event Type  Malfunction  
Manufacturer Narrative

(b)(4). Catalog# 00597909526 patella reamer blade with pilot hole lot# 64153510; catalog# 00597909526 patella reamer blade with pilot hole lot# 63980089. Foreign source: (b)(6). Reported event was unable to be confirmed due to limited information received from the customer. Device history record review was unable to be performed as the part and lot number of the device involved in the event is unknown. Root cause was unable to be determined. If any further information is found which would change or alter any conclusions or information, a supplemental will be filed accordingly. Zimmer biomet will continue to monitor for trends. Multiple mdr reports were filed for this event, please see associated reports: 0001822565-2018-07087; 0001822565-2018-07088.

 
Event Description

It was reported that the patella reamer blade would not assemble with the mating instrument. No adverse events have been reported as a result of the malfunction. No further event information available at the time of this report.

 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand NamePATELLA REAMER INSETTING GUIDE WITH COATING 26 MM DIAMETER
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 Key9111512
Report Number0001822565-2019-04153
Device Sequence Number1
Product CodeHTO
Report Source Manufacturer
Source Type DISTRIBUTOR,FOREIGN,HEALTH PR
Reporter Occupation
Type of Report Initial
Report Date 09/24/2019
1 Device Was Involved in the Event
0 PatientS WERE Involved in the Event:
Date FDA Received09/24/2019
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator HEALTH PROFESSIONAL
Device MODEL NumberN/A
Device Catalogue Number00512007026
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 Received09/23/2019
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
Is The Device Single Use? No
Is this a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Unkown
Removal/Correction NumberN/A

-
-