MAUDE Adverse Event Report: AESCULAP AG PATELLA 3-PEGS P2; KNEE ENDOPROSTHETICS

Model Number	NX042
Medical Device Problem Code	Loosening of Implant Not Related to Bone-Ingrowth (4002)
Health Effect - Clinical Codes	Ambulation or Postural Difficulties (2544); Joint Laxity (4526)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Nx049z.Device name as vega ps tibial plateau.Cemented t0.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.Ref.Code device name batch.Nx009z as vega ps femoral comp.Cemented f4n l 52137600.Nx100 vega ps gliding surface t0/0+ 10mm 51947691.Nn260p plug f/tibial plateau 52119154.Nx042 patella 3-pegs p2 52120719.Investigation: no product at hand.Therefore an investigation at the product 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 52137600.(2 as involved components).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 (vega loosening) a product safety case (psc) was initiated.
Event or Problem Description
It was reported that there was an issue with as vega knee.As a result of having the product implanted the patient has experienced knee pain, swelling, difficulty walking, and loosening and instability of the implant.The primary surgery occurred on (b)(6) 2015 and the revision surgery occurred on (b)(6) 2016.All available information has been provided at this time.If additional information becomes available the complaint will be updated accordingly.The adverse event / malfunction is filed under reference xc (b)(4).Associated medwatches: 2916714-2020-00411, 2916714-2020-00412, 2916714-2020-00413, and 2916714-2020-00414.Involved components: nx009z (ps femur cemented f4n lt), nx100 (ps pe insert t0/t0+, 10mm), nx049z (ps tibia cemented t0), nn260p (peek plug f/ tibia), nx042 (universal patella p2).The cement used is unidentified.

• Brand Name: PATELLA 3-PEGS P2
• Common Device Name: KNEE ENDOPROSTHETICS
• Manufacturer (Section D): AESCULAP AG; po box 40; tuttlingen, 78501 ; GM 78501
• MDR Report Key: 10601844
• Report Number: 2916714-2020-00415
• Device Sequence Number: 19651614
• Product Code: HRY
• UDI-Device Identifier: 04046963810283
• UDI-Public: 4046963810283
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Importer
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 09/29/2020

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
• Operator of Device: Health Professional
• Device Expiration Date: 02/29/2020
• Device Model Number: NX042
• Device Catalogue Number: NX042
• Device Lot Number: 52120719
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 10/15/2018
• Event Location: Hospital
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 09/29/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention