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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BIOMET UK LTD. OXF TWIN-PEG CMNTD FEM SM PMA; PROSTHESIS, KNEE

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BIOMET UK LTD. OXF TWIN-PEG CMNTD FEM SM PMA; PROSTHESIS, KNEE Back to Search Results
Model Number N/A
Device Problem Insufficient Information (3190)
Patient Problem No Information (3190)
Event Date 10/19/2017
Event Type  Injury  
Manufacturer Narrative
(b)(4).Multiple mdr's were submitted for this event.Please see reports: 3002806535 - 2017 - 01065.3002806535 - 2017 - 01066.3002806535 - 2017 - 01067.(b)(4).Concomitant products: 161468 oxf twin-peg cmntd fem sm pma, lot 769940.159532 oxf uni tib tray sz aa rm pma, lot 721200.159570 oxf anat brg rt sm size 5 pma, lot 032710.The investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.Not returned to manufacturer.
 
Event Description
It was reported that a patient underwent an initial right knee procedure.Subsequently, the patient was revised due to unknown reasons.Patient was converted from partial to total knee system.
 
Manufacturer Narrative
(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.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
OXF TWIN-PEG CMNTD FEM SM 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 Key7048588
MDR Text Key92623065
Report Number3002806535-2017-01065
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 02/13/2018
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 Number161468
Device Lot Number769940
Other Device ID NumberSEE H10 NARRATIVE
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Initial Date Manufacturer Received 10/25/2017
Initial Date FDA Received11/21/2017
Supplement Dates Manufacturer Received02/07/2018
Supplement Dates FDA Received02/13/2018
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured07/17/2015
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) Hospitalization; Required Intervention;
Patient Age68 YR
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