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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BIOMET UK LTD. OXFORD TWIN PEGGED CEMENTLESS FEMUR; PROSTHESIS, KNEE

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BIOMET UK LTD. OXFORD TWIN PEGGED CEMENTLESS FEMUR; PROSTHESIS, KNEE Back to Search Results
Model Number N/A
Device Problem Noise, Audible (3273)
Patient Problem Pain (1994)
Event Date 09/28/2017
Event Type  Injury  
Manufacturer Narrative
(b)(4).Multiple mdrs were submitted for this event.Please see reports: 0001825034 - 2017 - 09723.3002806535 - 2017 - 00984.(b)(4).Concomitant products: 161473 oxf twin peg cmntls lot r2409853a.159540 oxf anat brg lt sm lot 603270.Us166845 oxford cementless tibia a lm lot r3050449a.The investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.Device remains implanted.
 
Event Description
It was reported the patient twisted the knee and felt a "pop".Pain and tenderness were associated with the event.The patient was not revised and the event was treated with medicine and a brace.No further information has been made available at this time.
 
Manufacturer Narrative
(b)(4).This follow-up report is being submitted to relay additional information.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.
 
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Brand Name
OXFORD TWIN PEGGED CEMENTLESS FEMUR
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 Key6983290
MDR Text Key90417775
Report Number3002806535-2017-00981
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 distributor,health profession
Reporter Occupation Physician
Type of Report Initial,Followup
Report Date 01/09/2018
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 Physician
Device Model NumberN/A
Device Catalogue Number161473
Device Lot NumberR2409853A
Other Device ID NumberSEE H10 NARRATIVE
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Initial Date Manufacturer Received 10/01/2017
Initial Date FDA Received10/27/2017
Supplement Dates Manufacturer Received12/13/2017
Supplement Dates FDA Received01/09/2018
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured11/20/2015
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) Other;
Patient Age60 YR
Patient Weight70
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