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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ZIMMER BIOMET, INC. PERSONA ARTICULAR SURFACE FIXED BEARING POSTERIOR STABILIZED (PS) PROSTHESIS, KNEE

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ZIMMER BIOMET, INC. PERSONA ARTICULAR SURFACE FIXED BEARING POSTERIOR STABILIZED (PS) 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 femoral component size e catalog #: unknown lot #: unknown, unknown tibial component 13mm catalog #: unknown lot #: unknown, unknown patella 35mm 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.
 
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Brand NamePERSONA ARTICULAR SURFACE FIXED BEARING POSTERIOR STABILIZED (PS)
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 Key9375570
MDR Text Key168022687
Report Number0001822565-2019-04976
Device Sequence Number1
Product Code OIY
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K121771
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,consum
Reporter Occupation
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 Date04/30/2020
Device Model NumberN/A
Device Catalogue Number42522400713
Device Lot Number63029895
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? No
Event Location No Information
Date Manufacturer Received03/25/2020
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured05/14/2015
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: 11/26/2019 Patient Sequence Number: 1
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