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

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.

• 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 Key: 16026764
• MDR Text Key: 305932680
• Report Number: 9610612-2022-00377
• Device Sequence Number: 1
• Product Code: JWH
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K101281
• Number of Events Reported: 1
• 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 Number: NX009K
• Device Catalogue Number: NX009K
• Device Lot Number: 52743639
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 12/12/2022
• Initial Date FDA Received: 12/21/2022
• Supplement Dates Manufacturer Received: 01/05/2023
• Supplement Dates FDA Received: 01/17/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 02/15/2022
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Treatment: NS824R - LOT UNKNOWN
• Patient Outcome(s): Disability