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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: AESCULAP AG VEGA PS FEMORAL COMPONENT CEMENTED F4N L; KNEE ENDOPROSTHETICS

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AESCULAP AG VEGA PS FEMORAL COMPONENT CEMENTED F4N L; KNEE ENDOPROSTHETICS Back to Search Results
Model Number NX009K
Device Problem Difficult to Insert (1316)
Patient Problem Loss of Range of Motion (2032)
Event Date 12/12/2022
Event Type  Injury  
Manufacturer Narrative
Manufacturing site evaluation: investigation on-going.Additional information / investigation results will be provided in a supplemental report.
 
Event Description
It was reported that there was an issue with nx009k - vega ps femoral component cemented f4n l.According to the complaint description, the implant was difficult to insert.After the femoral trial and box trial size 4 were inserted, an implant of the same size was attempted to be inserted, but it did not fit along the osteotomy surface and the outer part floated up and was inserted in a flexed position.The implant will not be replaced, and at present, conservative therapy will be performed and the progress will be observed.There was impairment; however, the patient had no infection or other effect.Additional information was not provided.The adverse event is filed under aag reference (b)(4).
 
Event Description
Update: the adverse event is filed under aag reference (b)(4).Associated medwatch reports: nx009k (9610612-2022-00377) (b)(4).Ns304rm (9610612-2023-00012) (b)(4).Involved components: ns824r/vega ps removable trial femur box f4 - lot unknown (b)(4).
 
Manufacturer Narrative
Additional information: b5 - leading materials and involved components clarified.D10 - involved component.
 
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Brand Name
VEGA PS FEMORAL COMPONENT CEMENTED F4N L
Type of Device
KNEE ENDOPROSTHETICS
Manufacturer (Section D)
AESCULAP AG
po box 40
tuttlingen, 78501
GM  78501
Manufacturer (Section G)
AESCULAP AG
po box 40
tuttlingen, 78501
GM   78501
Manufacturer Contact
christian von der grün
po box 40
tuttlingen, 78501
GM   78501
MDR Report Key16026764
MDR Text Key305932680
Report Number9610612-2022-00377
Device Sequence Number1
Product Code JWH
Combination Product (y/n)N
Reporter Country CodeJA
PMA/PMN Number
K101281
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Foreign,Company Representative
Reporter Occupation Other Health Care Professional
Type of Report Initial,Followup
Report Date 01/17/2023
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 NumberNX009K
Device Catalogue NumberNX009K
Device Lot Number52743639
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Initial Date Manufacturer Received 12/12/2022
Initial Date FDA Received12/21/2022
Supplement Dates Manufacturer Received01/05/2023
Supplement Dates FDA Received01/17/2023
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured02/15/2022
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Patient Sequence Number1
Treatment
NS824R - LOT UNKNOWN
Patient Outcome(s) Disability;
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