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

MAUDE Adverse Event Report: BIOMET UK LTD. OXFORD UNI PH3 TIBIAL IMPACTOR; PROSTHESIS, KNEE

  • 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 UK LTD. OXFORD UNI PH3 TIBIAL IMPACTOR; PROSTHESIS, KNEE Back to Search Results
Model Number N/A
Device Problem Fracture (1260)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 12/07/2016
Event Type  malfunction  
Manufacturer Narrative
Current information is insufficient to permit a conclusion as to the cause of the event.The following sections could not be completed with the limited information provided.Expiration date - na.Date implanted - na.Date explanted - na.Manufacture date ¿ ni.
 
Event Description
During a partial knee arthroplasty the screw of the tibial impactor fractured during impaction.
 
Manufacturer Narrative
(b)(4).Reported event was confirmed by visual inspection of the returned device.Device history record (dhr) was reviewed and no discrepancies were found.Cause of the reported event was most likely due to customer error whilst using the device in situ.It can be concluded that the instrument returned in this evaluation was conforming to pre-defined drawing specification.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.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand Name
OXFORD UNI PH3 TIBIAL IMPACTOR
Type of Device
PROSTHESIS, KNEE
Manufacturer (Section D)
BIOMET UK LTD.
waterton industrial estates
bridgend CF31 3XA
UK  CF31 3XA
MDR Report Key6261738
MDR Text Key65208006
Report Number3002806535-2017-00033
Device Sequence Number1
Product Code NRA
Combination Product (y/n)N
PMA/PMN Number
PN/A
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type distributor,foreign,health pr
Type of Report Initial,Followup,Followup
Report Date 02/14/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Model NumberN/A
Device Catalogue Number32-420932
Device Lot NumberZB141001
Other Device ID NumberN/A
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer08/18/2017
Initial Date Manufacturer Received 12/19/2016
Initial Date FDA Received01/18/2017
Supplement Dates Manufacturer Received08/18/2017
01/24/2018
Supplement Dates FDA Received09/15/2017
02/16/2018
Is This a Reprocessed and Reused Single-Use Device? No
Removal/Correction NumberN/A
Patient Sequence Number1
-
-