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U.S. Department of Health and Human Services

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

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ZIMMER ORTHOPAEDIC MFG. LTD. 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)
Event Date 09/24/2019
Event Type  Injury  
Manufacturer Narrative
(b)(4). Concomitant medical device: persona femur cemented posterior stabilized (ps), catalog #: 42500607002, lot #: 64121962. Nexgen all poly patella, catalog #: 00597206638, lot #: 64163556. Tibia cemented 5 degree stemmed right size g, catalog #: 42532007902, lot #: 64281805. Cemented persona/ve surf & instruments, catalog #: 9800674105, lot #: unknown. Patella reamer blade with pilot hole 51 mm diameter single use only, catalog #: 00597909551, lot #: 64418785. Customer has indicated that the product will not be returned because it remains implanted. Reported event was unable to be confirmed due to limited information received from the customer. Device was not returned. Device history record (dhr) was reviewed and no discrepancies relevant to the reported event were found. Root cause was unable to be determined as the necessary information to adequately investigate the reported event was not provided. There are warnings in the package insert that this type of event can occur and risks are addressed in risk documentation.   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. The event was initially reported on 0001822565-2019-04931. Multiple mdr: 3007963827-2020-00076, 0001822565-2019-04932.
 
Event Description
It was reported that the patient underwent a knee arthroplasty. Subsequently, the patient alleges experiencing pain, stiffness and limited range of motion in knee. Further, the patient alleges uses a cane to ambulate and is scheduled to undergo a manipulation procedure. No revision procedure has been reported to date. 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 ORTHOPAEDIC MFG. LTD.
building no 2 east park
shannon industrial estate
shannon, county clare
EI
Manufacturer (Section G)
ZIMMER ORTHOPAEDIC MFG. LTD.
building no 2 east park
shannon industrial estate
shannon, county clare
EI
Manufacturer Contact
christina arnt
56 e. bell dr.
warsaw, IN 46582
5745273773
MDR Report Key9825963
MDR Text Key186529204
Report Number3007963827-2020-00075
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 consumer,distributor
Reporter Occupation
Type of Report Initial
Report Date 03/12/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received03/12/2020
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Model NumberN/A
Device Catalogue Number42522401012
Device Lot Number64363148
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 Received02/27/2020
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured04/18/2019
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: 03/12/2020 Patient Sequence Number: 1
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