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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ZIMMER BIOMET, INC. PERSONA ALL POLY PATELLA PROSTHESIS, KNEE

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ZIMMER BIOMET, INC. PERSONA ALL POLY PATELLA PROSTHESIS, KNEE Back to Search Results
Model Number N/A
Device Problem Insufficient Information (3190)
Patient Problems Muscular Rigidity (1968); Pain (1994); Limited Mobility Of The Implanted Joint (2671); Cancer (3262)
Event Type  Injury  
Manufacturer Narrative
(b)(4). Concomitant medical products: unknown tibial component 13mm catalog #: unknown lot #: unknown, unknown articular surface 8mm catalog #: unknown lot #: unknown, unknown femoral component size e catalog #: unknown lot #: unknown. The complainant has indicated that the product will not be returned because it remains implanted. The investigation is in process. Once the investigation has been completed, a follow-up mdr will be submitted. Multiple mdr reports were filled for this patient; please see all reports associated with this event: 0001822565-2019-04974, 0001822565-2019-04975, 0001822565-2019-04976, 0001822565-2019-05072. Remains implanted.
 
Event Description
It was reported that the patient underwent a knee arthroplasty. Subsequently, the patient was experiencing pain in knee and had limited range of motion. No revision procedure has been reported to date. However, the patient has been doing additional physical therapy. Attempt for further information has been made, but no further information has been provided.
 
Event Description
No further event information available at the time of this report.
 
Manufacturer Narrative
Udi #: (b)(4). Concomitant medical products: persona femur cemented posterior stabilized (ps) standard catalog # 42500606402 lot # 63362725, persona stemmed tibia catalog # 42532007102 lot # 63315961, persona articular surface fixed bearing posterior stabilized (ps) catalog # 42522400713 lot # 63029895, 3. 5mm hex head screw x38mm catalog # 20800000018 lot # unknown. Multiple mdr reports were filled for this event: 3007963827-2020-00037. 3007963827-2020-00038.
 
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Brand NamePERSONA ALL POLY PATELLA
Type of DevicePROSTHESIS, KNEE
Manufacturer (Section D)
ZIMMER BIOMET, INC.
56 e. bell drive
warsaw IN 46582
MDR Report Key9375550
MDR Text Key168052784
Report Number0001822565-2019-05072
Device Sequence Number1
Product Code OIY
Combination Product (y/n)N
PMA/PMN Number
K121771
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,consum
Type of Report Initial,Followup,Followup
Report Date 03/31/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received11/26/2019
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date04/30/2021
Device Model NumberN/A
Device Catalogue Number42540200035
Device Lot Number63326893
Was Device Available for Evaluation? No
Was the Report Sent to FDA? No
Event Location No Information
Date Manufacturer Received03/25/2020
Is This a Reprocessed and Reused Single-Use Device? No
Removal/Correction NumberN/A

Patient Treatment Data
Date Received: 11/26/2019 Patient Sequence Number: 1
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