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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ZIMMER BIOMET, INC. PERSONA PARTIAL TIBIAL CEMENTED; PROSTHESIS, KNEE
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ZIMMER BIOMET, INC. PERSONA PARTIAL TIBIAL CEMENTED; PROSTHESIS, KNEE Back to Search Results
Model Number N/A
Device Problem No Apparent Adverse Event (3189)
Patient Problem Pain (1994)
Event Date 01/01/2018
Event Type  Injury  
Manufacturer Narrative
(b)(4).Foreign: (b)(6).Concomitant medical products: persona partial femur cemented cat#: 42558000302, lot#: 63760813, persona partial articular surface cat#:42528200508, lot#: 63449777.Customer has indicated that the product will not be returned to zimmer biomet for investigation, as the product remains implanted.The investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.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.Multiple mdr reports were filed for this event, please see associated reports:0001822565 - 2018 - 05937, 0001822565 - 2018 - 05938, 0001822565 - 2018 - 05939.Product remains implanted.
 
Event Description
It was reported that the study patient was reported on-going pain in study knee at 1 year follow up.
 
Manufacturer Narrative
The following sections have been corrected:no hospitalization was reported (b)(4).Reported event was unable to be confirmed due to limited information received from the customer.Device history record (dhr) was reviewed and no discrepancies relevant to the reported event were found.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.
 
Event Description
No further event information available at the time of this report.
 
Event Description
Upon reassessment of the reported event, it was determined an mdr should not have been filed under the current mfr number.This event will be reported under 0001825034-2020-02038.
 
Manufacturer Narrative
Upon reassessment of the reported event, it was determined an mdr should not have been filed under the current mfr number.This event will be reported under 0001825034-2020-02038.
 
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Brand Name
PERSONA PARTIAL TIBIAL CEMENTED
Type of Device
PROSTHESIS, KNEE
Manufacturer (Section D)
ZIMMER BIOMET, INC.
56 e. bell drive
warsaw IN 46582
MDR Report Key8023286
MDR Text Key125600851
Report Number0001822565-2018-05938
Device Sequence Number1
Product Code HSX
Combination Product (y/n)N
PMA/PMN Number
K161592
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type foreign,health professional,s
Type of Report Initial,Followup,Followup
Report Date 05/19/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received10/31/2018
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator Health Professional
Device Model NumberN/A
Device Catalogue Number42538000502
Device Lot Number63632020
Was Device Available for Evaluation? No
Was the Report Sent to FDA? No
Date Manufacturer Received05/15/2020
Is This a Reprocessed and Reused Single-Use Device? No
Removal/Correction NumberN/A
Patient Sequence Number1
Patient Outcome(s) Hospitalization; Other;
Patient Weight86
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