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

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)
Date of Event	10/24/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Reference code: (b)(4).Device name as vega ps tibial plateau; cemented t3+; serial number: n/a.Batch number: 52128662; udi device identifier: (b)(4); udi production identifier: (b)(4).Basic udi: di n/a; unit of use udi: di 4046963810474.Ref.Code; device name; batch#: (b)(4); patella 3-pegs p2 52259408; (b)(4); as vega ps femoral comp.Cemented f6n r 52204662; (b)(4); as tibial obturator d14mm 52218381; (b)(4); vega ps gliding surface t3/3+ 10mm 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: 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: 52259408.(all registered as involved components).There are 2 similar complaints against the same lot number: 52218381:(all registered as involved components).Explanation and rationale: in the light of the little information received, and due to the circumstance that we did not receive 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 a vega knee components.As a result of having the product implanted the patient has experienced knee pain, swelling, difficulty walking, loosening, and instability of the implant.The primary surgery occurred on (b)(6) 2016, and the revision surgery occurred on (b)(6) 2017.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: (b)(4).Involved components: nx042 (universal patella p2); nx033z(ps femur cemented f6n rt); nn264z(tibial obturator d14mm, l7mm); nx056z(ps tibia cemented t3+); nx130 (ps pe insert t3/t3+, 10mm).Associated medwatches: 2916714-2020-00477; 2916714-2020-00478; 2916714-2020-00479; 2916714-2020-00480.

• Brand Name: PATELLA 3-PEGS P2
• Common Device Name: KNEE ENDOPROSTHESES
• Manufacturer (Section D): AESCULAP AG; po box 40; tuttlingen, 78501 ; GM 78501
• MDR Report Key: 10653156
• Report Number: 2916714-2020-00476
• Device Sequence Number: 2963124
• Product Code: JWH
• UDI-Device Identifier: 04046963810283
• UDI-Public: 4046963810283
• Combination Product (Y/N): N
• Initial Reporter State: AL
• 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): 10/08/2020

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: 06/30/2021
• Device Model Number: NX042
• Device Catalogue Number: NX042
• Device Lot Number: 52259408
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 10/24/2018
• Event Location: Hospital
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 10/08/2020
• 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