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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ZIMMER BIOMET, INC. FEMORAL COMPONENT SIZE E LEFT PROSTHESIS, KNEE

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ZIMMER BIOMET, INC. FEMORAL COMPONENT SIZE E LEFT PROSTHESIS, KNEE Back to Search Results
Model Number N/A
Device Problems Unstable (1667); Detachment of Device or Device Component (2907); Migration (4003)
Patient Problems Failure of Implant (1924); Inflammation (1932); Scar Tissue (2060); Synovitis (2094); Joint Dislocation (2374); Muscle/Tendon Damage (4532); Swelling/ Edema (4577)
Event Date 11/22/2021
Event Type  Injury  
Manufacturer Narrative
(b)(4). Concomitant devices - unknown nexgen rotating hinge knee tibial component catalog #: ni lot #: ni, unknown nexgen rotating hinge knee articular surface catalog #: ni lot #: ni. The product could not be evaluated and the reported event was not confirmed. The device history records could not be reviewed as the lot number associated with the reported event is unknown. A definitive root cause could not be determined with the information provided. 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.
 
Event Description
It was reported that the patient underwent a knee arthroplasty revision to address the femoral screw backing out approximately ten (10) months post-operatively and repair a quarter-size hole in the quadriceps tendon. The patient completed seven (7) weeks of stabilization with a full-length leg cast and then received a full leg brace restricting to 60 degrees and physical therapy. Attempts have been made, however, no additional information is available.
 
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Brand NameFEMORAL COMPONENT SIZE E LEFT
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 Key13655963
MDR Text Key286490088
Report Number0001822565-2022-00617
Device Sequence Number1
Product Code KRO
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K013385
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Other,Consumer,Health Professional
Reporter Occupation
Type of Report Initial,Followup,Followup
Report Date 03/30/2022
2 Devices were Involved in the Event: 1   2  
1 Patient was Involved in the Event
Date FDA Received03/02/2022
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Model NumberN/A
Device Catalogue Number00588001501
Device Lot Number64690229
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? No
Date Manufacturer Received03/29/2022
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured05/18/2020
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: 03/02/2022 Patient Sequence Number: 1
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