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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ZIMMER BIOMET, INC. PATELLA REAMER BLADE; KNEE INSTRUMENT

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ZIMMER BIOMET, INC. PATELLA REAMER BLADE; KNEE INSTRUMENT Back to Search Results
Model Number N/A
Device Problem Positioning Failure (1158)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 06/04/2019
Event Type  malfunction  
Manufacturer Narrative
(b)(4).Concomitant medical products: patella reamer blade; p/n: 00597909541, l/n: 64018812.Pat rmr bld; p/n: 00597909546, l/n: 64270358.Report source: (b)(6).Customer has indicated that the product will be returned to zimmer biomet for investigation.The investigation is in process once the investigation has been completed, a follow-up mdr will be submitted.Multiple mdr reports were filed for this event, please see associated reports: 0001822565 - 2019 - 02769, 0001822565 - 2019 - 02770.
 
Event Description
It was reported during surgery that an instrument will not mate with compatible instrument as expected during use.Subsequently, the surgery was completed with a different instrument.Attempts have been made and no further information has been provided.
 
Manufacturer Narrative
Complaint sample was evaluated and the reported event was not confirmed.Visual examination of the returned product identified no sign of use.Instrument passes both functional tests and dimensional analysis.Dhr was reviewed and no discrepancies were found.Root cause was unable to be determined.A summary of the investigation has been sent to the complainant.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
PATELLA REAMER BLADE
Type of Device
KNEE INSTRUMENT
Manufacturer (Section D)
ZIMMER BIOMET, INC.
56 e. bell drive
warsaw IN 46582
MDR Report Key8750407
MDR Text Key149806985
Report Number0001822565-2019-02769
Device Sequence Number1
Product Code HTO
Combination Product (y/n)N
PMA/PMN Number
EXEMPT
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type distributor,foreign,health pr
Type of Report Initial,Followup
Report Date 12/19/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Model NumberN/A
Device Catalogue Number00597909541
Device Lot Number64018812
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer07/25/2019
Was the Report Sent to FDA? No
Initial Date Manufacturer Received 06/07/2019
Initial Date FDA Received07/01/2019
Supplement Dates Manufacturer Received12/18/2019
Supplement Dates FDA Received12/19/2019
Is This a Reprocessed and Reused Single-Use Device? No
Removal/Correction NumberN/A
Patient Sequence Number1
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