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

Model Number	NX042
Medical Device Problem Codes	Mechanical Problem (1384); Loosening of Implant Not Related to Bone-Ingrowth (4002)
Health Effect - Clinical Codes	Joint Laxity (4526); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/13/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Manufacturing evaluation: investigation on-going.Should additional relevant information become available, a supplemental medwatch report will be provided.
Event or Problem Description
It was reported to aesculap inc.That an as vega knee implant, comprised of the following components, as vega ps femoral comp.Cemented f3n r (part # nx027z) (ref.Associated mdr id 2916714-2020-00439), a patella 3-pegs p2 (part # nx042), a as vega ps tibial plateau cemented t1 (part # nx051z) (ref.Associated mdr id 2916714-2020-00441), a vega ps gliding surface t0/0+ 10mm (part # nx100) (ref.Associated mdr id 2916714-2020-00442), a plug f/tibial plateau (part # nn260p) (ref.Associated mdr id 2916714-2020-00443), was implanted on (b)(6) 2012.According to the complainant, the patient experienced loosening of the as vega knee, which resulted in a revision surgery being performed on (b)(6) 2019.The cement used during the primary surgery is unknown.No known adverse patient effects occurred as a result of the revision surgery.The complaint device is not available to be returned to the manufacturer for evaluation.Additional information has been requested, but has not been made available.The adverse event / malfunction is filed under (b)(4) reference xc (b)(4).Involved components: nx027z - as vega ps femoral comp.Cemented f3n r - lot # unknown, nx042 - patella 3-pegs p2 - lot # unknown, nx051z - as vega ps tibial plateau cemented t1 - lot # unknown, nx100 - vega ps gliding surface t0/0+ 10mm - lot # unknown, nn260p - plug f/tibial plateau - lot # unknown.
Additional Manufacturer Narrative
Associated medwatches: 2916714-2020-00439; 2916714-2020-00440; 2916714-2020-00441; 2916714-2020-00442; 2916714-2020-00443.Reference code nx051z.Device name as vega ps tibial plateau cemented t1 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.Nx027z as vega ps femoral comp.Cemented f3n r unknown.Nx042 patella 3-pegs p2 unknown.Nx100 vega ps gliding surface t0/0+ 10mm unknown.Nn260p plug f/tibial plateau unknown.Investigation.No product at hand.Therefore an investigation at the product 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 (vega loosening) a product safety case (psc) was initiated.
Event or Problem Description
No updates.

• 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: 10535595
• Report Number: 2916714-2020-00440
• Device Sequence Number: 3311950
• 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
• Device Implanted Year: 2012
• Device Explanted Year: 2019
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Importer
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 10/06/2020
• Report Date (Section F): 09/15/2020

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 Model Number: NX042
• Device Catalogue Number: NX042
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 09/30/2020
• Event Location: Hospital
• Date Report to Manufacturer: 08/19/2020
• Initial Date Received by Manufacturer: Not provided
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 09/15/2020
• Supplement Report FDA Received Date: 10/06/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: NN260P - PLUG F/TIBIAL PLATEAU.; NX027Z - AS VEGA PS FEMORAL COMP.CEMENTED F3N R.; NX051Z - AS VEGA PS TIBIAL PLATEAU CEMENTED T1.; NX100 - VEGA PS GLIDING SURFACE T0/0+ 10MM.
• Outcome Attributed to Adverse Event: Required Intervention
• Date Report Sent to FDA: 09/15/2020