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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ZIMMER BIOMET, INC. FEMUR TRABECULAR METAL POSTERIOR STABILIZED (PS) NARROW POROUS PROSTHESIS KNEE

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ZIMMER BIOMET, INC. FEMUR TRABECULAR METAL POSTERIOR STABILIZED (PS) NARROW POROUS PROSTHESIS KNEE Back to Search Results
Model Number N/A
Device Problems Noise, Audible (3273); Migration (4003)
Patient Problems Pain (1994); Loss of Range of Motion (2032)
Event Date 04/23/2020
Event Type  Injury  
Manufacturer Narrative

Cmp-(b)(4). Age or date of birth: (b)(6). Concomitant medical products: persona stemmed 5-degree tibia, catalog #: 42532007502, lot #: 63563513. Persona ps articular surface fixed bearing posterior stabilization (ps), catalog #: 42521400811, lot #: 62236779. Persona all poly patella, catalog #: 42540000032, lot #: 63518729. Report source: (b)(6). Customer has indicated that the product will not be returned because it remains implanted. The investigation is in process. Multiple mdr reports were filled for this event: 0001822565-2021-01236, 0001822565-2021-01237, 0002648920-2021-00106.

 
Event Description

It was reported that the patient underwent a knee arthroplasty. Subsequently, the patient is experiencing pain, range of motion, at the three year clinical visit abnormal patellar tracking is noted, along with abnormal patella height, with crepitus/clunk/restricted mobility.

 
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Brand NameFEMUR TRABECULAR METAL POSTERIOR STABILIZED (PS) NARROW POROUS
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 Key11772986
MDR Text Key251157805
Report Number0001822565-2021-01234
Device Sequence Number1
Product Code MBH
Combination Product (Y/N)N
Reporter Country CodeFR
PMA/PMN NumberK122745
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type COMPANY REPRESENTATIVE,FOREIG
Reporter Occupation
Type of Report Initial,Followup
Report Date 05/28/2021
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received05/04/2021
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator HEALTH PROFESSIONAL
Device MODEL NumberN/A
Device Catalogue Number42500206802
Device LOT Number63434674
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 Received05/05/2021
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
Date Device Manufactured08/15/2016
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: 05/04/2021 Patient Sequence Number: 1
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