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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 SHIM KNEE INSTRUMENT

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ZIMMER BIOMET, INC. PERSONA CONSTRAINED TIBIAL ARTICULAR SURFACE PROVISIONAL SHIM KNEE INSTRUMENT Back to Search Results
Model Number N/A
Device Problems Fracture (1260); Component Missing (2306)
Patient Problem No Information (3190)
Event Type  malfunction  
Manufacturer Narrative
(b)(4). Concomitant medical product: persona constrained tibial articular surface provisional shim, catalog # 42527900200, lot # 62400298. The complaint device has been returned, but the device investigation has not yet been completed. The investigation is in process. Once the investigation has been completed, a follow-up mdr will be submitted. Multiple mdr reports were filled for this event: 0001822565-2018-01298.
 
Event Description
It was reported that the device was noticed to be fractured, worn, and missing a ball bearing. No adverse events were reported with this event.
 
Manufacturer Narrative
This follow-up report is being submitted to relay additional information. Complaint sample was evaluated and the reported event was confirmed. Product was returned and visual examination of the returned parts shows signs of repeated use and missing ball bearings. Dhr was reviewed and no discrepancies were found. Review of the complaint history determined that no further action is required. The root cause of the reported issue is attributed to design deficiency. 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 SHIM
Type of DeviceKNEE INSTRUMENT
Manufacturer (Section D)
ZIMMER BIOMET, INC.
56 e. bell drive
warsaw IN 46582
Manufacturer (Section G)
ZIMMER BIOMET, INC.
56 e. bell drive
warsaw IN 46582
Manufacturer Contact
christina arnt
56 e. bell dr.
warsaw, IN 46582
5745273773
MDR Report Key7315898
MDR Text Key101618941
Report Number0001822565-2018-01299
Device Sequence Number1
Product Code OIY
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
PK123459
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type distributor,health profession
Reporter Occupation Medical Equipment Company Technician/Representative
Type of Report Initial,Followup
Report Date 03/13/2018
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received03/06/2018
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model NumberN/A
Device Catalogue Number42527900400
Device Lot Number62383735
Other Device ID NumberN/A
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer02/08/2018
Is the Reporter a Health Professional? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received03/12/2018
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured05/24/2013
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Unkown
Removal/Correction NumberZ-1052-2015

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