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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BIOMET UK LTD. OXF UNI TIB TRAY SZ B LM PMA; PROSTHESIS, KNEE

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BIOMET UK LTD. OXF UNI TIB TRAY SZ B LM PMA; PROSTHESIS, KNEE Back to Search Results
Catalog Number 154720
Device Problem Migration or Expulsion of Device (1395)
Patient Problem Swelling (2091)
Event Type  Injury  
Manufacturer Narrative
(b)(4).Concomitant products: oxford femoral catalog# 161469 lot# 504950, oxford bearing catalog# 159548 lot# 437610, cobalt bone cement catalog# 402282 lot# 699600, oxford resection catalog# 506124 lot# 942051, guide catalog# 42-411572 lot# 111189.Customer has indicated that the product will not be returned to zimmer biomet for investigation as it remains implanted.The investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.
 
Event Description
It was reported that patient is scheduled for a revision due to tibial loosening after approximately three years post implantation.
 
Manufacturer Narrative
(b)(4).This follow-up report is being submitted to relay additional information.(b)(4).Reported event was unable to be confirmed due to limited information received from the customer.Device history record (dhr) was reviewed and no discrepancies were found.Root cause was unable to be determined as the necessary information to adequately investigate the reported event was not provided.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.
 
Event Description
It was reported that patient underwent a revision due to tibial loosening after approximately three years post implantation.
 
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Brand Name
OXF UNI TIB TRAY SZ B LM PMA
Type of Device
PROSTHESIS, KNEE
Manufacturer (Section D)
BIOMET UK LTD.
waterton industrial estates
bridgend CF31 3XA
UK  CF31 3XA
Manufacturer (Section G)
BIOMET UK LTD.
waterton industrial estates
bridgend CF31 3XA
UK   CF31 3XA
Manufacturer Contact
christina arnt
56 e. bell dr.
warsaw, IN 46582
5745273773
MDR Report Key6658556
MDR Text Key78126212
Report Number3002806535-2017-00522
Device Sequence Number1
Product Code NRA
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
PP010014
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type consumer
Reporter Occupation Other
Type of Report Initial,Followup
Report Date 12/15/2017
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Expiration Date04/30/2023
Device Catalogue Number154720
Device Lot Number3002828 
Other Device ID NumberSEE H10 NARRATIVE
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? No
Initial Date Manufacturer Received 05/22/2017
Initial Date FDA Received06/21/2017
Supplement Dates Manufacturer Received11/16/2017
Supplement Dates FDA Received12/15/2017
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured04/15/2013
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
Patient Sequence Number1
Patient Outcome(s) Required Intervention;
Patient Weight76
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