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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ZIMMER, INC. PERSONA PS VE ARTICULAR SURFACE FIXED BEARING POSTERIOR STABILIZED RIGHT 10 MM PROTHESIS, KNEE

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ZIMMER, INC. PERSONA PS VE ARTICULAR SURFACE FIXED BEARING POSTERIOR STABILIZED RIGHT 10 MM PROTHESIS, KNEE Back to Search Results
Catalog Number 42522400710
Device Problem Difficult to Insert (1316)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Type  malfunction  
Manufacturer Narrative
This follow-up report is being submitted to relay additional information. Complaint sample was evaluated and the reported event was confirmed. Visual inspection of the returned articular surface indicated gouging on the posterior of the post and in the insertion slot on the distal side which may have been caused during several attempts to reinsert the articular surface. Dimensional analysis of the returned articular surface confirms product is within specification. Device history record was reviewed and no discrepancies were found. Review of the complaint history determined that no further action is required as no trends were identified. Root cause was unable to be determined. There are warnings in the package insert that this type of event can occur and instructions for appropriate insertion of an articular surface, including never reinserting an articular surface after an unsuccessful attempt. 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
(b)(4). Concomitant medical products: item name: persona stemmed cemented 5 degree right size e tibia, item number: 42532007102, lot number: 63233576.
 
Event Description
It was reported the articular surface would not engage with tibial tray.
 
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Brand NamePERSONA PS VE ARTICULAR SURFACE FIXED BEARING POSTERIOR STABILIZED RIGHT 10 MM
Type of DevicePROTHESIS, KNEE
Manufacturer (Section D)
ZIMMER, INC.
1800 west center street
warsaw IN 46580
Manufacturer (Section G)
ZIMMER, INC.
1800 west center street
warsaw IN 46580
Manufacturer Contact
christina arnt
56 e. bell dr.
warsaw, IN 46582
5745273773
MDR Report Key6300239
MDR Text Key134106168
Report Number0001822565-2017-00553
Device Sequence Number1
Product Code OIY
Combination Product (y/n)N
Reporter Country CodeJA
PMA/PMN Number
PK121771
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Reporter Occupation
Type of Report Initial,Followup
Report Date 12/04/2017
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received02/03/2017
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date05/31/2021
Device Catalogue Number42522400710
Device Lot Number63364175
Other Device ID NumberSEE H10
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer04/10/2017
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received12/04/2017
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured06/01/2016
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Removal/Correction NumberN/A

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