MAUDE Adverse Event Report: AESCULAP AG S VEGA PS TIBIAL PLATEAU CEMENTED T0; KNEE ENDOPROSTHESES

Model Number	NX049Z
Medical Device Problem Code	Patient Device Interaction Problem (4001)
Health Effect - Clinical Codes	Pain (1994); Ambulation or Postural Difficulties (2544)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Investigation results: reference code nx049z device name as vega ps tibial plateau cemented t0 serial number n/a batch number 51938559 manufacturing date 30.04.2013 reference code device name corresponding internal notification number: nx007z as vega ps femoral comp.Cemented f3n l 400479180 nn260p plug f/tibial plateau 400479181 nx042 patella 3-pegs p2 400479183 nx102 vega ps gliding surface t0/0+ 14mm 400479184 investigation: no products are available.Therefore a failure description 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 leading device(s) 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: unfortunately due to a lack of data and without the product we cannot determine the exact root cause for the mentioned deviation.Corrective action: for this topic (implant loosening) a product safety case (psc) was initiated.
Event or Problem Description
It was reported to aesculap inc.That a vega knee implant system was implanted during a primary surgery performed on april 21, 2015.According to the complainant, following the primary surgery, the patient experienced pain and difficulty walking of the implant.The patient underwent a revision surgery on (b)(6) 2018.The complaint device was not available to be returned to the manufacturer for evaluation.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: nx007z (ps femur cemented f3n lt); nn260p (peek plug f/ tibia); nx049z (ps tibia cemented t0); nx042 (universal patella p2); nx102 (ps pe insert t0/t0+, 14mm) cement used is unknown.Associated medwatches: 2916714-2020-00312, 2916714-2020-00313, (b)(4), 2916714-2020-00315, 2916714-2020-00316.

• Brand Name: S VEGA PS TIBIAL PLATEAU CEMENTED T0
• Common Device Name: KNEE ENDOPROSTHESES
• Manufacturer (Section D): AESCULAP AG; po box 40; tuttlingen, 78501 ; GM 78501
• MDR Report Key: 11381707
• Report Number: 2916714-2020-00314
• Device Sequence Number: 3767793
• Product Code: JWH
• UDI-Device Identifier: 04046963810337
• UDI-Public: 4046963810337
• 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: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 02/25/2021
• Report Date (Section F): 02/25/2021

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: 03/01/2023
• Device Model Number: NX049Z
• Device Catalogue Number: NX049Z
• Device Lot Number: 51938559
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: Yes
• Distributor Facility Aware Date: 07/20/2018
• Device Age: 5 YR
• Event Location: Hospital
• Date Report to Manufacturer: 07/20/2018
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 02/25/2021
• 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: 02/25/2021