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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ZIMMER BIOMET, INC. UNKNOWN ROTATING HINGE KNEE ARTICULAR SURFACE PROSTHESIS, KNEE

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ZIMMER BIOMET, INC. UNKNOWN ROTATING HINGE KNEE ARTICULAR SURFACE PROSTHESIS, KNEE Back to Search Results
Model Number N/A
Device Problem Insufficient Information (3190)
Patient Problems Hematoma (1884); Blood Loss (2597)
Event Date 10/16/2017
Event Type  Injury  
Manufacturer Narrative
(b)(4) date of birth: (b)(6). Concomitant medical product: unknown rotating hinge knee femoral, catalog #: unknown, lot #: unknown, unknown rotating hinge knee tibial tray, catalog #: unknown, lot #: unknown. (b)(6) customer has indicated that the product will not be returned to zimmer biomet for investigation, as product location is unknown. 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. Multiple mdr reports were filed for this event, please see associated reports: 0001822565-2018-01180, 0001822565-2018-01182. Remains implanted.
 
Event Description
It was reported that the patient underwent a procedure to remove a hematoma. It was also noted that the patient lost approximately 500 ml of blood during this procedure. Attempts have been made and no further information has been provided.
 
Manufacturer Narrative
Reported event was unable to be confirmed as part number / lot number of device involved in the incident is unknown. Device history record (dhr) review was unable to be performed as the lot number of the device involved in the event is unknown. Root cause was unable to be determined as the necessary information to adequately investigate the reported event was not 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.
 
Manufacturer Narrative
Concomitant medical products: unknown rhk straight stem extension, catalog #: unknown, lot #: unknown. 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. Multiple mdr reports were filed for this event, please see associated reports: 0001822565-2018-01180, 0001822565-2018-01182, 0001822565-2018-02524.
 
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Brand NameUNKNOWN ROTATING HINGE KNEE ARTICULAR SURFACE
Type of DevicePROSTHESIS, KNEE
Manufacturer (Section D)
ZIMMER BIOMET, INC.
56 e. bell drive
warsaw IN 46582
MDR Report Key7293789
MDR Text Key100845886
Report Number0001822565-2018-01181
Device Sequence Number1
Product Code KRO
Combination Product (y/n)N
PMA/PMN Number
PN/A
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type foreign,health professional
Type of Report Initial,Followup,Followup
Report Date 05/04/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received02/23/2018
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Model NumberN/A
Other Device ID NumberN/A
Was Device Available for Evaluation? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received05/01/2018
Is This a Reprocessed and Reused Single-Use Device? No
Removal/Correction NumberN/A

Patient Treatment Data
Date Received: 02/23/2018 Patient Sequence Number: 1
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