MAUDE Adverse Event Report: AESCULAP AG PLUG F/TIBIAL PLATEAU; KNEE ENDOPROSTHETICS

Model Number NN260P

Device Problems Loose or Intermittent Connection (1371); Loosening of Implant Not Related to Bone-Ingrowth (4002)

Patient Problems No Known Impact Or Consequence To Patient (2692); No Clinical Signs, Symptoms or Conditions (4582)

Event Date 04/22/2019

Event Type  Injury  

Manufacturer Narrative

If follow-up information or manufacturing investigation is provided, a supplement will be submitted.

Event Description

It was reported that there was an issue with as vega knee.It was reported that as a result of having the product implanted, the patient has experienced loosening which resulted in a revision surgery.The primary procedure occurred on (b)(6) 2013, and the revision was performed on (b)(6) 2019.All available information has been provided at this time, if additional information becomes available the complaint will be updated accordingly.Involved components: as vega system ps, as patella p2, as vega ps tibial plateau cemented, as vega ps gliding surface t1/t1 + 12mm, as vega peek plug t1 - t5.The adverse event / malfunction is filed under reference (b)(4).Associated medwatches: 2916714-2020-00434, 2916714-2020-00435, 2916714-2020-00436, 2916714-2020-00437.

Event Description

No updates.

Manufacturer Narrative

Associated medwatches: 2916714-2020-00434, 2916714-2020-00435, 2916714-2020-00436, 2916714-2020-00437.Reference code nx051z device name as vega ps tibial plateau cemented t1 udi device identifier (b)(4).Unit of use udi-(b)(4).Ref.Code device name batch nx009z as vega ps femoral comp.Cemented f4n l unknown nx042 patella 3-pegs p2 unknown nx111 vega ps gliding surface t1/1+ 12mm unknown nn260p plug f/tibial plateau unknown investigation no product at hand.Therefore an investigation at the device is not possible.Pictorial documentation there are no pictures available.Batch history review due to the fact that no lot number was provided, a review of the device history records for the complained device is not possible.Explanation and rationale 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.Corrective action for this topic (loosening) a product safety case (psc) was initiated.

• Brand Name: PLUG F/TIBIAL PLATEAU
• Type of Device: KNEE ENDOPROSTHETICS
• Manufacturer (Section D): AESCULAP AG; po box 40; tuttlingen, 78501 ; GM 78501
• MDR Report Key: 10504695
• MDR Text Key: 206103724
• Report Number: 2916714-2020-00438
• Device Sequence Number: 1
• Product Code: HRY
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Distributor
• Type of Report: Initial,Followup
• Report Date: 10/16/2020

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: NN260P
• Device Catalogue Number: NN260P
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 10/16/2020
• Distributor Facility Aware Date: 09/29/2020
• Event Location: Hospital
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 09/08/2020
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 10/16/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention