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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ZIMMER BIOMET, INC. VANGUARD CR ILOK FEM-LT 67.5; PROSTHESIS, KNEE

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ZIMMER BIOMET, INC. VANGUARD CR ILOK FEM-LT 67.5; PROSTHESIS, KNEE Back to Search Results
Model Number N/A
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Pain (1994); Loss of Range of Motion (2032)
Event Date 11/27/2017
Event Type  Injury  
Manufacturer Narrative
(b)(4).Concomitant medical product: vanguard tibial bearing 10x71/75, catalog: 183440, lot: 630980; polished finned tibial tray 71mm, catalog: 141253, lot: 2014070113; series a pat std 31 3 peg 184764, lot: 426800.Multiple mdr reports were filed for this event, please see associated reports: 0001825034-2019-02348.The product will not be returned to zimmer biomet for investigation.The investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.
 
Event Description
It was reported the patient underwent a manipulation under anesthesia approximately one month post total knee arthroplasty due to unexplained pain and limited range of motion.No further intervention was reported.
 
Manufacturer Narrative
This follow-up report is being submitted to relay additional information.Medical records were reviewed and identified limited flexion and extension as well as unexplained pain and confirmed the manipulation under anesthesia.Device history record was reviewed and no discrepancies were found.A definitive root cause cannot be determined.If any further information is found which would change or alter any conclusions or information, a supplemental report will be filed accordingly.Zimmer biomet will continue to monitor for trends.
 
Event Description
No additional information reported.
 
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Brand Name
VANGUARD CR ILOK FEM-LT 67.5
Type of Device
PROSTHESIS, KNEE
Manufacturer (Section D)
ZIMMER BIOMET, INC.
56 e. bell drive
warsaw IN 46582
MDR Report Key8651204
MDR Text Key146406107
Report Number0001825034-2019-02347
Device Sequence Number1
Product Code HRY
Combination Product (y/n)N
PMA/PMN Number
K113550
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type foreign,health professional,s
Type of Report Initial,Followup
Report Date 10/08/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Model NumberN/A
Device Catalogue Number183030
Device Lot NumberJ3953848
Was Device Available for Evaluation? No
Was the Report Sent to FDA? No
Initial Date Manufacturer Received 05/07/2019
Initial Date FDA Received05/29/2019
Supplement Dates Manufacturer Received10/03/2019
Supplement Dates FDA Received10/08/2019
Is This a Reprocessed and Reused Single-Use Device? No
Removal/Correction NumberN/A
Patient Sequence Number1
Patient Outcome(s) Required Intervention;
Patient Weight75
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