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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ZIMMER BIOMET, INC. ARTICULAR SURFACE FIXED BEARING CRUCIATE RETAINING (CR) RIGHT 10 MM HEIGHT PROSTHESIS, KNEE

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ZIMMER BIOMET, INC. ARTICULAR SURFACE FIXED BEARING CRUCIATE RETAINING (CR) RIGHT 10 MM HEIGHT PROSTHESIS, KNEE Back to Search Results
Model Number N/A
Device Problem Unstable (1667)
Patient Problem No Information (3190)
Event Date 10/01/2015
Event Type  Injury  
Manufacturer Narrative
(b)(4). Concomitant medical products: persona femur trabecular metal cr standard porous cat#: 42502806602 lot#: 62643713, persona articular surface fixed bearing cr cat#: 42522000510 lot#: 62493556, nexgen tm standard primary patella cat#: 00587806535 lot#: 62491771. Customer has indicated that the product will not be returned to zimmer biomet for investigation, as product location is unknown. These products are used for treatment. No devices were received; therefore, the device history records were reviewed for deviations and/or anomalies with no anomalies/deviations identified that are related to this event. However, as there is insufficient information to allow for selection of a root cause. Root cause is unknown. No corrective or preventive actions are needed at this time. Zimmer biomet will continue to monitor for trends. Product location is unknown.
 
Event Description
Revision due to instability.
 
Manufacturer Narrative
The complaint reported issues of migration and instability are confirmed, based on the revision operative notes. The devices were not returned for further examination. Dhr was reviewed and no discrepancies relevant to the reported event were found. Review of the complaint history determined that no further action is required. A definitive root cause cannot be determined with the information 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.
 
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Brand NameARTICULAR SURFACE FIXED BEARING CRUCIATE RETAINING (CR) RIGHT 10 MM HEIGHT
Type of DevicePROSTHESIS, 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 Key7373448
MDR Text Key103557687
Report Number0001822565-2018-01797
Device Sequence Number1
Product Code OIY
Combination Product (y/n)N
PMA/PMN Number
PK121771
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type health professional,other
Reporter Occupation
Type of Report Initial,Followup,Followup
Report Date 01/02/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received03/27/2018
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date10/31/2018
Device Model NumberN/A
Device Catalogue Number42522000510
Device Lot Number62493556
Other Device ID NumberN/A
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer05/09/2019
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? No
Event Location No Information
Date Manufacturer Received12/30/2019
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured10/29/2013
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

Patient Treatment Data
Date Received: 03/27/2018 Patient Sequence Number: 1
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