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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BIOMET UK LTD. OXFORD PKS ANATOMICAL MEN BEARING LEFT; PROSTHESIS, KNEE

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BIOMET UK LTD. OXFORD PKS ANATOMICAL MEN BEARING LEFT; PROSTHESIS, KNEE Back to Search Results
Model Number N/A
Device Problems Inadequacy of Device Shape and/or Size (1583); Packaging Problem (3007)
Patient Problem No Information (3190)
Event Type  Injury  
Manufacturer Narrative
(b)(4).Report source- foreign.The event occurred in (b)(6).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 the patient was revised to address the implantation of the wrong size poly bearing.Surgeon alleged the clear, outer film of the packaging obstructed part of the device label, which led to the incorrect size being implanted.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.Dhr review was unable to be performed as the lot number of the device involved in the event is unknown.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 PKS ANATOMICAL MEN BEARING LEFT
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 Key7048190
MDR Text Key92618940
Report Number3002806535-2017-01054
Device Sequence Number1
Product Code NRA
Combination Product (y/n)N
Reporter Country CodeGM
PMA/PMN Number
PP010014
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type distributor,foreign,health pr
Reporter Occupation Physician
Type of Report Initial,Followup
Report Date 03/22/2018
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? Yes
Device Operator Physician
Device Model NumberN/A
Device Catalogue NumberUNKNOWN
Other Device ID NumberN/A
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Initial Date Manufacturer Received 10/24/2017
Initial Date FDA Received11/21/2017
Supplement Dates Manufacturer Received03/07/2018
Supplement Dates FDA Received03/22/2018
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
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;
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