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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ZIMMER BIOMET, INC. UNKNOWN KNEE; PROSTHESIS KNEE

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ZIMMER BIOMET, INC. UNKNOWN KNEE; PROSTHESIS KNEE Back to Search Results
Model Number N/A
Device Problem Insufficient Information (3190)
Patient Problem Unspecified Infection (1930)
Event Type  Injury  
Manufacturer Narrative
Sherman, k.; goodfellow, j.; tibrewal, s.; o¿connor, j.(1985) bilateral oxford meniscal knee arthroplasty.Journal of the royal society of medicine volume 78 november 1985, 916-919.Product was not returned to zimmer biomet for investigation.Without the opportunity to examine the complaint product, root cause cannot be determined.Without the opportunity to examine the complaint product, root cause cannot be determined.Part and lot identification are necessary for review of manufacturing records, deviation history, and complaint history, neither were 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.(b)(4).
 
Event Description
It was reported one patient was identified in the article who underwent arthrodesis due to infection following knee arthroplasty on unknown date.There has been no further information provided and the patient outcome is unknown.All other events will be reported in individual records which will be linked to this parent record.
 
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Brand Name
UNKNOWN KNEE
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 Key6936149
MDR Text Key89087169
Report Number0001825034-2017-08336
Device Sequence Number1
Product Code NRA
Combination Product (y/n)N
Reporter Country CodeUK
PMA/PMN Number
PUNKNOWN
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type distributor,foreign,literatur
Reporter Occupation Other
Type of Report Initial
Report Date 10/10/2017
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 Model NumberN/A
Device Catalogue NumberUNKNOWN KNEE
Device Lot NumberUNKNOWN
Other Device ID NumberN/A
Was Device Available for Evaluation? No
Initial Date Manufacturer Received 07/20/2015
Initial Date FDA Received10/10/2017
Was Device Evaluated by Manufacturer? Yes
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) Required Intervention;
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