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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ZIMMER BIOMET, INC. PPK TIBIAL CUTTING BLOCK INSTRUMENT, KNEE

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ZIMMER BIOMET, INC. PPK TIBIAL CUTTING BLOCK INSTRUMENT, KNEE Back to Search Results
Model Number N/A
Device Problems Fracture (1260); Mechanical Jam (2983)
Patient Problem No Information (3190)
Event Date 08/24/2017
Event Type  malfunction  
Manufacturer Narrative
(b)(4). Foreign (b)(6). It is unknown if product will be returning to zimmer biomet and 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.
 
Event Description
It was reported that during a right total knee arthroplasty, when fixing the tibial cutting block, two pins got stuck in the vertical slot.
 
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Brand NamePPK TIBIAL CUTTING BLOCK
Type of DeviceINSTRUMENT, KNEE
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 Key7645618
MDR Text Key112749645
Report Number0001825034-2018-04289
Device Sequence Number1
Product Code HTJ
Combination Product (y/n)N
Reporter Country CodeSZ
PMA/PMN Number
PEXEMPT
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type foreign,health professional
Reporter Occupation
Type of Report Initial,Followup
Report Date 11/21/2018
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received06/28/2018
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model NumberN/A
Device Catalogue Number42-5399-052-85
Other Device ID NumberN/A
Was Device Available for Evaluation? No Answer Provided
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? No
Event Location No Information
Date Manufacturer Received11/16/2018
Was Device Evaluated by Manufacturer? No
Is the Device Single Use? No Answer Provided
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Unkown
Removal/Correction NumberN/A

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