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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ZIMMER BIOMET, INC. NEXGEN SIZING PLATE FOR STEMMED TIBIAL SIZE 5 INSTRUMENT

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ZIMMER BIOMET, INC. NEXGEN SIZING PLATE FOR STEMMED TIBIAL SIZE 5 INSTRUMENT Back to Search Results
Model Number N/A
Device Problems Positioning Failure (1158); Loose or Intermittent Connection (1371)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 06/14/2019
Event Type  Injury  
Manufacturer Narrative
(b)(4). Customer has indicated that the product is in process of being returned to zimmer biomet for investigation. Once the investigation has been completed, a follow-up mdr will be submitted. Concomitant medical products: locking tibial tray provisional handle, item # 00597709600, lot # 60714066. Multiple mdr reports were filed for this event, please see associated reports: 0001822565-2019-02818.
 
Event Description
It was reported that during an initial surgery that the tibial plate, locks on too loosely and insecurely to the provisional handle. Attempts have been made, and no further information has been provided.
 
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Brand NameNEXGEN SIZING PLATE FOR STEMMED TIBIAL SIZE 5
Type of DeviceINSTRUMENT
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 Key8760458
MDR Text Key150014210
Report Number0001822565-2019-02817
Device Sequence Number1
Product Code LHX
Combination Product (y/n)N
Reporter Country CodeSN
PMA/PMN Number
EXEMPT
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 10/23/2019
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received07/03/2019
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model NumberN/A
Device Catalogue Number00597701205
Device Lot Number60074761
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer07/29/2019
Is the Reporter a Health Professional?
Was the Report Sent to FDA? No
Event Location No Information
Date Manufacturer Received10/18/2019
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured07/28/2003
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Unkown
Removal/Correction NumberN/A

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