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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ZIMMER BIOMET, INC. ARTICULAR SURFACE MEDIAL CONGRUENT (MC) RIGHT 10 MM HEIGHT PROSTHESIS, KNEE

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ZIMMER BIOMET, INC. ARTICULAR SURFACE MEDIAL CONGRUENT (MC) RIGHT 10 MM HEIGHT PROSTHESIS, KNEE Back to Search Results
Model Number N/A
Device Problems Adverse Event Without Identified Device or Use Problem (2993); Insufficient Information (3190)
Patient Problem Loss of Range of Motion (2032)
Event Date 08/27/2019
Event Type  Injury  
Manufacturer Narrative
(b)(4). Concomitant medical products: persona femur cruciate retaining (cr) catalog 42502206402 lot 64071413, nexgen complete knee solution, trabecular metal patella catalog 00587806532 lot 64176468, natural tibia trabecular metal fixed bearing right size d catalog 42530006702 lot 62869826. The product will not be returned to zimmer biomet for investigation as it remains implanted. Once the investigation has been completed, a follow-up mdr will be submitted. Multiple mdr reports were filed for this event, please see associated reports: 0001822565-2019-04181, 0001822565-2019-04182.
 
Event Description
A patient enrolled in a clinical study underwent right knee arthroplasty and was noted to have stiffness and decreased range of motion during their one month follow-up visit. Patient underwent a manipulation under anesthesia approximately two weeks later.
 
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Brand NameARTICULAR SURFACE MEDIAL CONGRUENT (MC) RIGHT 10 MM HEIGHT
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 Key9134990
MDR Text Key160847453
Report Number0001822565-2019-04181
Device Sequence Number1
Product Code OIY
UDI-Device Identifier00889024468177
UDI-Public(01)00889024468177
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K150090
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,health
Reporter Occupation
Type of Report Initial,Followup,Followup
Report Date 03/02/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received09/30/2019
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date08/31/2022
Device Model NumberN/A
Device Catalogue Number42522100110
Device Lot Number63753017
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 Manufactured09/06/2017
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: 09/30/2019 Patient Sequence Number: 1
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