MAUDE Adverse Event Report: AESCULAP AG AS VEGA PS TIBIAL PLATEAU CEMENTED T0; KNEE ENDOPROSTHETICS

Model Number NX049Z

Device Problem Loosening of Implant Not Related to Bone-Ingrowth (4002)

Patient Problem Joint Disorder (2373)

Event Date 01/17/2020

Event Type  Injury  

Manufacturer Narrative

If additional information or evaluation results become available, a supplemental report will be submitted.

Event Description

It was reported that there was an issue with as vega ps tibial plateau.According to the customer description, as a result of having the product implanted, the patient has experienced loosening of as vega knee, which resulted in a revision surgery.The primary surgery occurred on (b)(6) 2012, and the revision surgery occurred on, (b)(6) 2020.All available information has been provided at this time, if additional information becomes available the complaint will be updated accordingly.Involved components: as vega ps femoral comp.Cemented f3n r-nx027z-unknown.Patella 3-pegs p2 -nx042-unknown.Vega ps gliding surface t0/0+ 10mm-nx100-unknown.Plug f/tibial plateau-nn260p-unknown.Additional information was not provided nor available / was not available.Additional patient information is not available.The adverse event / malfunction is filed under aag reference (b)(4).

Event Description

Invovled components as vega ps femoral comp.Cemented f3n r-nx027z-unknown.Patella 3-pegs p2 -nx042-unknown.Vega ps gliding surface t0/0+ 10mm-nx100-unknown.Plug f/tibial plateau-nn260p-unknown.

Manufacturer Narrative

No product at hand.Therefore an investigation at the product is not possible.Due to the fact that no lot number was provided, a review of the device history records for the complained device is not possible.In the light of the little information received and due the circumstance that we did not received the complained devices it is not possible to determine a root cause for the mentioned failure.

• Brand Name: AS VEGA PS TIBIAL PLATEAU CEMENTED T0
• Type of Device: KNEE ENDOPROSTHETICS
• Manufacturer (Section D): AESCULAP AG; po box 40; tuttlingen, 78501 ; GM 78501
• MDR Report Key: 10516428
• MDR Text Key: 206500999
• Report Number: 9610612-2020-00485
• Device Sequence Number: 1
• Product Code: JWH
• Combination Product (y/n): N
• PMA/PMN Number: K101281
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 10/26/2020

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: NX049Z
• Device Catalogue Number: NX049Z
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 08/19/2020
• Initial Date FDA Received: 09/10/2020
• Supplement Dates Manufacturer Received: 09/30/2020
• Supplement Dates FDA Received: 10/26/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: NN260P-UNKNOWN.; NX027Z-UNKNOWN.; NX042-UNKNOWN.; NX100-UNKNOWN.
• Patient Outcome(s): Required Intervention