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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: . ALL-POLY PATELLA CEMENTED 29 MM DIAMETER PROSTHESIS, KNEE

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. ALL-POLY PATELLA CEMENTED 29 MM DIAMETER PROSTHESIS, KNEE Back to Search Results
Model Number N/A
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problem Pain (1994)
Event Date 02/15/2017
Event Type  Injury  
Manufacturer Narrative
(b)(4). Concomitant medical products: catalog number: 42512000413 lot number: 62470468 brand : persona cr ve articular surface, catalog number: 42-5320-067-01 lot number:63553382 brand : persona stemmed 5 degree tibia, catalog number: 42557000114 lot number:63575982 brand : persona str smooth stems, catalog number: 42502006601 lot number:62789215 brand : persona cr narrow femoral. Multiple mdr reports were filed for this event, please see associated reports: 0001822565 -2018 -06608, 0001822565 -2018 -06609, 0001822565 -2018 -06610, 0001822565 -2018 -06611. Product has not been returned to zimmer biomet. The investigation is in process. Once the investigation has been completed, a follow-up mdr will be submitted. Device remains implanted in the patient.
 
Event Description
It was reported that the patient underwent a total knee arthroplasty. Subsequently, the patient is suffering from pain post surgery. No revision occurred, implant remains in patient. No additional information on the reported event is unavailable.
 
Manufacturer Narrative
Reported event was unable to be confirmed due to limited information received from the customer. Device history record was reviewed and no discrepancies 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.
 
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Brand NameALL-POLY PATELLA CEMENTED 29 MM DIAMETER
Type of DevicePROSTHESIS, KNEE
Manufacturer (Section D)
.
56 e. bell drive
warsaw IN 46582
MDR Report Key8117744
MDR Text Key128860612
Report Number0001822565-2018-06612
Device Sequence Number1
Product Code OIY
Combination Product (y/n)N
PMA/PMN Number
K121771
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,health
Type of Report Initial,Followup
Report Date 02/19/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received11/29/2018
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Expiration Date08/31/2021
Device Model NumberN/A
Device Catalogue Number42540200029
Device Lot Number63432254
Was Device Available for Evaluation? No
Was the Report Sent to FDA? No
Event Location No Information
Date Manufacturer Received02/15/2019
Is This a Reprocessed and Reused Single-Use Device? No
Removal/Correction NumberN/A

Patient Treatment Data
Date Received: 11/29/2018 Patient Sequence Number: 1
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