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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ZIMMER BIOMET, INC. PERSONA UNI PARTIAL ARTICULAR SURFACE; PROSTHESIS, KNEE
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ZIMMER BIOMET, INC. PERSONA UNI PARTIAL ARTICULAR SURFACE; PROSTHESIS, KNEE Back to Search Results
Model Number N/A
Device Problem Insufficient Information (3190)
Patient Problem Unspecified Infection (1930)
Event Date 09/11/2018
Event Type  Injury  
Manufacturer Narrative
(b)(4).Concomitant medical products: partial femur cemented size 3 left medial cat#: 42-5580-003-01, lot#:64036254, partial tibial cemented size g left medial cat#: 42-5380-007-01, lot#: unk.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.Product location unknown.
 
Event Description
It was reported that the patient was revised due to infection two months after initial knee procedure.It was reported the patient presented as infected, joint was extensively debrided and washed out, the articular surface was replaced.
 
Manufacturer Narrative
This follow-up report is being filed to relay that the previous report submitted on oct 3, 2018 was submitted erroneously under the wrong manufacturing report number.This event is currently being submitted under 0001825034-2019-02812.
 
Event Description
This follow-up report is being filed to relay that the previous report submitted on oct 3, 2018 was submitted erroneously under the wrong manufacturing report number.This event is currently being submitted under 0001825034-2019-02812.
 
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Brand Name
PERSONA UNI PARTIAL ARTICULAR SURFACE
Type of Device
PROSTHESIS, KNEE
Manufacturer (Section D)
ZIMMER BIOMET, INC.
56 e. bell drive
warsaw IN 46582
MDR Report Key7931855
MDR Text Key122619438
Report Number0001822565-2018-05354
Device Sequence Number1
Product Code HSX
Combination Product (y/n)N
PMA/PMN Number
PK161592
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type distributor,foreign
Type of Report Initial,Followup
Report Date 06/28/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator Health Professional
Device Expiration Date09/28/2022
Device Model NumberN/A
Device Catalogue Number42518200708
Device Lot Number63785406
Was Device Available for Evaluation? No
Was the Report Sent to FDA? No
Initial Date Manufacturer Received 09/11/2018
Initial Date FDA Received10/03/2018
Supplement Dates Manufacturer Received06/24/2019
Supplement Dates FDA Received06/28/2019
Is This a Reprocessed and Reused Single-Use Device? No
Removal/Correction NumberN/A
Patient Sequence Number1
Patient Outcome(s) Hospitalization; Required Intervention;
Patient Weight41
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