MAUDE Adverse Event Report: AESCULAP AG PATELLA 3-PEGS P3; KNEE ENDOPROSTHETICS

Model Number NX043

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

Patient Problems Pain (1994); Ambulation Difficulties (2544); Swelling/ Edema (4577)

Event Type  Injury  

Manufacturer Narrative

Reference code nx031z.Device name as vega ps femoral comp.Cemented f5n r.Serial number n/a.Batch number unknown.Udi device identifier (b)(4).Udi production identifier unknown.Basic udi-di n/a.Unit of use udi-di (b)(4).Manufacturing date unknown.Reference code nx054z.Device name as vega ps tibial plateau cemented t2+.Serial number n/a.Batch number 51790770.Udi device identifier (b)(4).Udi production identifier (b)(4).Basic udi-di n/a.Unit of use udi-di (b)(4).Manufacturing date 2011-10-11.Ref.Code device name batch.Nx043 patella 3-pegs p3 51844942.Nx120 vega ps gliding surface t2/2+ 10mm 51799158.Nn260p plug f/tibial plateau 51878787.Investigation: no product at hand.Therefore an investigation at the device is not possible.Pictorial documentation: there are no pictures available.Batch history review: the device quality and manufacturing history records (dhr) have been checked for all available lot numbers and the products found to be according to our specification valid at the time of production.There are 3 similar complaints against the same lot number 5187878 (all registered as involved component).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.

Event Description

It was reported that there was an issue with a vega knee.It was reported that as a result of having the products implanted, the patient has experienced pain and swelling in both knees; normal daily activities were restricted due to this pain.The primary procedure occurred on (b)(6) 2012, and the revision was performed on (b)(6) 2016.Intraoperative findings were loosening of the tibial and femoral component.All available information has been provided at this time, if additional information becomes available the complaint will be updated accordingly.Involved components: nx031z (ps femur cemented f5n rt).Nx043 (universal patella p3).Nx054z (ps tibia cemented t2+).Nx120 (ps pe insert t2/t2+, 10mm).Nn260p (peek plug f/ tibia).The cement used was not specified.The adverse event / malfunction is filed under reference xc 100026350.Associated medwatches: 2916714-2020-00495, 2916714-2020-00497, 2916714-2020-00498, 2916714-2020-00499.

• Brand Name: PATELLA 3-PEGS P3
• Type of Device: KNEE ENDOPROSTHETICS
• Manufacturer (Section D): AESCULAP AG; po box 40; tuttlingen, 78501 ; GM 78501
• MDR Report Key: 10816408
• MDR Text Key: 217447453
• Report Number: 2916714-2020-00496
• Device Sequence Number: 1
• Product Code: HRY
• UDI-Device Identifier: 04046963810290
• UDI-Public: 4046963810290
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Distributor
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 11/10/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/10/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 03/01/2017
• Device Model Number: NX043
• Device Catalogue Number: NX043
• Device Lot Number: 51844942
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 11/10/2020
• Distributor Facility Aware Date: 02/15/2019
• Event Location: Hospital
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention