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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BIOMET UK LTD. OXFORD UNI TIB TRAY SZ E LM PMA; PROSTHESIS, KNEE, FEMOROTIBIAL, UNICOMPARTMENTAL

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BIOMET UK LTD. OXFORD UNI TIB TRAY SZ E LM PMA; PROSTHESIS, KNEE, FEMOROTIBIAL, UNICOMPARTMENTAL Back to Search Results
Model Number N/A
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Pain (1994); Joint Laxity (4526)
Event Date 03/12/2024
Event Type  Injury  
Manufacturer Narrative
(b)(4).D-10: oxf twin-peg cmntd fem lg pma, item# 161470, lot# 65766772.Oxf anat brg lt lg size 3 pma, item# 159554, lot# 164780.Refobacin bc r 1x40 us, item# 110034355, lot# ax18ad0402.The device will not be returned for analysis; however, an investigation of the reported event is in progress.Once the investigation is completed, a supplemental medwatch 3500a will be submitted.
 
Event Description
It was reported that the patient underwent an initial partial left knee replacement.Subsequently, the patient has moderate pain and medial collateral ligament instability.The patient sustained two falls, both falls the patient reported tripping.Attempts have been made and no further information has been provided.
 
Event Description
No further event information available at the time of this report.
 
Manufacturer Narrative
This follow-up report is being submitted to relay additional corrected information.The products remain implanted; therefore, visual and dimensional evaluations could not be performed.A review of the device manufacturing records confirmed no abnormalities or deviations that could be related to the reported event.Reported event was confirmed by review of medical records.X-ray findings confirmed components in good position without evidence of loosening, neutral tracking patella.With the available information, a definitive root cause could not be determined.If any further information is found which would change or alter any conclusions or information, a supplemental report will be filed accordingly.Zimmer biomet will continue to monitor for trends.
 
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Brand Name
OXFORD UNI TIB TRAY SZ E LM PMA
Type of Device
PROSTHESIS, KNEE, FEMOROTIBIAL, UNICOMPARTMENTAL
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 Key19057977
MDR Text Key339551175
Report Number3002806535-2024-00125
Device Sequence Number1
Product Code NRA
UDI-Device Identifier05019279388929
UDI-Public(01)05019279388929(17)320520(10)024450
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
P010014
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Study,Health Professional,Company Representative
Reporter Occupation Physician
Type of Report Initial,Followup
Report Date 05/08/2024
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? No
Device Operator Lay User/Patient
Device Model NumberN/A
Device Catalogue Number154726
Device Lot Number024450
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? No
Initial Date Manufacturer Received 03/12/2024
Initial Date FDA Received04/08/2024
Supplement Dates Manufacturer Received05/02/2024
Supplement Dates FDA Received05/08/2024
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured05/20/2022
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Patient Sequence Number1
Patient Outcome(s) Hospitalization; Required Intervention;
Patient SexMale
Patient Weight145 KG
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