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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ZIMMER BIOMET, INC. OXF PKS ANAT MEN BRG UHMWPE RT SML SZ 3; PROSTHESIS, KNEE

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ZIMMER BIOMET, INC. OXF PKS ANAT MEN BRG UHMWPE RT SML SZ 3; PROSTHESIS, KNEE Back to Search Results
Model Number N/A
Device Problem Appropriate Term/Code Not Available (3191)
Patient Problems Cyst(s) (1800); Debris, Bone Shedding (1803)
Event Date 10/08/2015
Event Type  Injury  
Manufacturer Narrative
Zimmer biomet complaint-(b)(4).Customer has indicated that the product will not be returned to zimmer biomet for investigation as it was discarded.Reported event was unable to be confirmed due to limited information received from the customer.Dhr was reviewed and no discrepancies were found.Review of the complaint history determined that no further action is required as no were trends identified.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.This report is being submitted late as it has been identified in remediation.
 
Event Description
It was reported that patient took part in oxford minimum 5 year study.The patient was revised to a total knee due to lateral progression, osteophytes, bone cysts, eburnated bone, and bone loss.
 
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Brand Name
OXF PKS ANAT MEN BRG UHMWPE RT SML SZ 3
Type of Device
PROSTHESIS, KNEE
Manufacturer (Section D)
ZIMMER BIOMET, INC.
56 e. bell drive
warsaw IN 46582
Manufacturer (Section G)
ZIMMER BIOMET, INC.
56 e. bell drive
warsaw IN 46582
Manufacturer Contact
christina arnt
56 e. bell dr.
warsaw, IN 46582
5745273773
MDR Report Key7121992
MDR Text Key95003940
Report Number0001825034-2017-11215
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 company representative,health
Reporter Occupation Physician
Type of Report Initial
Report Date 12/14/2017
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? No
Device Operator Health Professional
Device Expiration Date05/01/2013
Device Model NumberN/A
Device Catalogue Number159568
Device Lot Number526944
Other Device ID NumberN/A
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Initial Date Manufacturer Received 01/12/2016
Initial Date FDA Received12/15/2017
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured06/04/2008
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 Age77 YR
Patient Weight72
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