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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ZIMMER BIOMET, INC. ARTICULAR SURFACE W/ HINGE POST SCREW ENCLOSEDSIZE D 17 MM; PROSTHESIS, KNEE

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ZIMMER BIOMET, INC. ARTICULAR SURFACE W/ HINGE POST SCREW ENCLOSEDSIZE D 17 MM; PROSTHESIS, KNEE Back to Search Results
Model Number N/A
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problem Unspecified Infection (1930)
Event Type  Injury  
Manufacturer Narrative
(b)(4).Event date: unknown date in (b)(6) 2013.Explant date: unknown date in (b)(6) 2013.Therapy date: unknown date in (b)(6) 2013.Medical devices: unknown femoral catalog#: ni lot#: ni, unknown tibial tray catalog#: ni lot#: ni.Customer has indicated that the product will not be returned to zimmer biomet for investigation, as its location is unknown.The investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.
 
Event Description
It was reported the patient underwent a right knee revision approximately six months post-implantation due to infection.Attempts have been made and no further information has been provided.
 
Event Description
No further event information available at the time of this report.
 
Manufacturer Narrative
This follow-up report is being submitted to relay additional information.Updated: b4, g4, g7, h2, h3, h6, and h10.Reported event was unable to be confirmed due to limited information received from the customer.Device history record (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.
 
Manufacturer Narrative
This follow-up report is being submitted to relay a correction.No product was returned or pictures provided; visual and dimensional evaluations could not be performed.Lot identification is necessary for review of device history records, lot identification was not provided.A definitive root cause cannot be determined.His complaint was not confirmed.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.
 
Event Description
No further event information available at the time of this report.
 
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Brand Name
ARTICULAR SURFACE W/ HINGE POST SCREW ENCLOSEDSIZE D 17 MM
Type of Device
PROSTHESIS, KNEE
Manufacturer (Section D)
ZIMMER BIOMET, INC.
56 e. bell drive
warsaw IN 46582
MDR Report Key10817643
MDR Text Key215551022
Report Number0001822565-2020-03761
Device Sequence Number1
Product Code KRO
Combination Product (y/n)N
PMA/PMN Number
N/A
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type consumer,health professional
Type of Report Initial,Followup,Followup
Report Date 06/14/2021
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 Number00588004017
Device Lot NumberUNKNOWN
Was Device Available for Evaluation? No
Was the Report Sent to FDA? No
Initial Date Manufacturer Received 10/15/2020
Initial Date FDA Received11/10/2020
Supplement Dates Manufacturer Received11/10/2020
05/17/2021
Supplement Dates FDA Received11/11/2020
06/14/2021
Is This a Reprocessed and Reused Single-Use Device? No
Removal/Correction NumberN/A
Patient Sequence Number1
Treatment
SEE H10.
Patient Outcome(s) Hospitalization; Required Intervention;
Patient Weight73
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