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

Model Number	NN260P
Medical Device Problem Code	Loosening of Implant Not Related to Bone-Ingrowth (4002)
Health Effect - Clinical Codes	Pain (1994); Ambulation or Postural Difficulties (2544); Swelling/ Edema (4577)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Reference code (b)(4).Device name as vega ps femoral comp.Cemented.F5n r.Serial number n/a.Batch number 51782846.Udi device identifier (b)(4).Udi production identifier (b)(4).Basic udi-di n/a.Unit of use udi-di (b)(4).Manufacturing date 2011-09-02.Reference code (b)(4).Device name as vega ps tibial plateau.Cemented t3.Serial number n/a.Batch number 51842695.Udi device identifier (b)(4).Udi production identifier (b)(4).Basic udi-di n/a.Unit of use udi-di (b)(4).Manufacturing date 2012-04-12.Ref.Code device name batch.Nx044 patella 3-pegs p4 51710759.Nx130 vega ps gliding surface t3/3+ 10mm 51802972.Nn260p plug f/tibial plateau 51841772.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 no similar complaints against the same lot number (s) with this error pattern.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 or Problem Description
It was reported that there was an issue with a vega knee.The patient has experienced pain and swelling in right knee, and normal daily activities were restricted due to this pain.The primary surgery occurred on (b)(6) 2012, and the revision surgery occurred on (b)(6) 2018.Intraoperative findings during replacement surgery were loosening of the tibial and femoral components, which had resulted in a revision surgery.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), nx044 (universal patella p4), nx055z (ps tibia cemented t3), nx130 (ps pe insert t3/t3+, 10mm), nn260p (peek plug f/ tibia).The cement used was not specified.The adverse event / malfunction is filed under reference (b)(4).Associated medwatches: 2916714-2020-00631, 2916714-2020-00632, 2916714-2020-00633, and 2916714-2020-00634.

• Brand Name: PLUG F/TIBIAL PLATEAU
• Common Device Name: KNEE ENDOPROSTHETICS
• Manufacturer (Section D): AESCULAP AG; po box 40; tuttlingen, 78501 ; GM 78501
• MDR Report Key: 10969770
• Report Number: 2916714-2020-00635
• Device Sequence Number: 19907464
• Product Code: HRY
• UDI-Device Identifier: 04046963711320
• UDI-Public: 4046963711320
• 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): N
• Reporter Type: Importer
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 12/08/2020
• Report Date (Section F): 12/08/2020

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: 03/01/2017
• Device Model Number: NN260P
• Device Catalogue Number: NN260P
• Device Lot Number: 51841772
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: Yes
• Distributor Facility Aware Date: 04/08/2019
• Event Location: Hospital
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 12/08/2020
• 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
• Date Report Sent to FDA: 12/08/2020