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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ZIMMER BIOMET, INC. PERSONA CONSTRAINED TIBIAL ARTICULAR SURFACE PROVISIONAL PROSTHESIS, KNEE

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ZIMMER BIOMET, INC. PERSONA CONSTRAINED TIBIAL ARTICULAR SURFACE PROVISIONAL PROSTHESIS, KNEE Back to Search Results
Model Number N/A
Device Problem Fracture (1260)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 11/07/2018
Event Type  Injury  
Manufacturer Narrative
(b)(4). Customer has indicated that the product will not be returned because product 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 that the device fractured while trialing during procedure.
 
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. Reported event was unable to be confirmed due to limited information received from the customer. Device was not returned. Device history record (dhr) was reviewed and no discrepancies relevant to the reported event were found. Reported information states that the surgeon was using a mallet to impact the tasp. The persona surgical technique (97-5026-001-00, rev 11) instructs to apply gentle manual pressure without impacting the tasp construct with either a mallet or hand. The root cause is considered to be misuse as the surgeon impacted the tasp. 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 NamePERSONA CONSTRAINED TIBIAL ARTICULAR SURFACE PROVISIONAL
Type of DevicePROSTHESIS, KNEE
Manufacturer (Section D)
ZIMMER BIOMET, INC.
56 e. bell drive
warsaw IN 46582
MDR Report Key8130916
MDR Text Key129293108
Report Number0001822565-2018-06692
Device Sequence Number1
Product Code OIY
Combination Product (y/n)N
PMA/PMN Number
K123459
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type distributor,health profession
Type of Report Initial,Followup,Followup
Report Date 04/25/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received12/04/2018
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Model NumberN/A
Device Catalogue Number42527600303
Device Lot Number63015210
Was Device Available for Evaluation? No
Was the Report Sent to FDA? No
Event Location No Information
Date Manufacturer Received04/25/2019
Is This a Reprocessed and Reused Single-Use Device? No
Removal/Correction NumberN/A

Patient Treatment Data
Date Received: 12/04/2018 Patient Sequence Number: 1
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