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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ZIMMER BIOMET, INC. ARTICULAR SURFACE; PROSTHESIS, KNEE
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ZIMMER BIOMET, INC. ARTICULAR SURFACE; PROSTHESIS, KNEE Back to Search Results
Model Number N/A
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problem Unspecified Infection (1930)
Event Date 12/12/2019
Event Type  Injury  
Manufacturer Narrative
(b)(4).Customer has indicated that the product will not be returned to zimmer biomet for investigation, as the device was requested but not returned by the hospital.The investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.Concomitant medical products: 42502607002, femoral component, lot # 64142984, 42532007902, tibial component, lot # 64072981.Report source: (b)(6).Multiple mdr reports were filed for this event, please see associated reports: 3007963827 - 2020 - 00004, 3007963827 - 2020 - 00005.
 
Event Description
It was reported that approximately 11 months post implantation, the patient had all implants removed due to infection.Attempts have been made and no further information has been provided.
 
Manufacturer Narrative
Upon receipt of additional information, it has been determined that this device was reported under the incorrect manufacturing site mfr number.The initial report was forwarded in error and should be voided.Please see 3007963827 - 2020 - 00009.
 
Event Description
Upon receipt of additional information, it has been determined that this device was reported under the incorrect manufacturing site mfr number.The initial report was forwarded in error and should be voided.Please see 3007963827 - 2020 - 00009.
 
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Brand Name
ARTICULAR SURFACE
Type of Device
PROSTHESIS, KNEE
Manufacturer (Section D)
ZIMMER BIOMET, INC.
56 e. bell drive
warsaw IN 46582
MDR Report Key9540134
MDR Text Key173452541
Report Number0001822565-2020-00018
Device Sequence Number1
Product Code MBH
Combination Product (y/n)N
PMA/PMN Number
K150090
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type distributor,foreign,health pr
Type of Report Initial,Followup
Report Date 01/07/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received01/02/2020
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Model NumberN/A
Device Catalogue Number42522100911
Was Device Available for Evaluation? No
Was the Report Sent to FDA? No
Date Manufacturer Received01/03/2020
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Treatment
SEE H10
Patient Outcome(s) Hospitalization; Required Intervention;
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