MAUDE Adverse Event Report: AESCULAP AG VEGA PS GLIDING SURFACE T5 14MM; KNEE ENDOPROSTHESES

Model Number	NX152
Medical Device Problem Code	Loosening of Implant Not Related to Bone-Ingrowth (4002)
Health Effect - Clinical Codes	Joint Laxity (4526); Implant Pain (4561)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Investigation results: reference code (b)(4), device name as vega ps tibial plateau cemented t5, serial number n/a, batch number 52130710, manufacturing date 15.04.2015.Reference code device name corresponding internal notification number: (b)(4) as vega ps femoral comp.Cemented f5n l 400481992, (b)(4) vega ps gliding surface t5 14mm 400481994, (b)(4) as tibial obturator d14mm 400481995.Investigation no products available.Therefore a failure description at the products are 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 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 that there was an issue with a vega knee components.As a result of having an aesculap product implanted, the patient has experienced knee pain and loosening of the implant.The primary surgery occurred on (b)(6) 2015, which included non-aesculap implants.A revision to replace non-aesculap products with aesculap implants occurred on (b)(6) 2017, and there was no reported second revision surgery.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: (b)(4) (ps femur cemented f5n lt), (b)(4)(ps tibia cemented t5), (b)(4) (ps pe insert t5, 14mm), (b)(4) (tibial obturator d14mm, l7mm).Associated medwatches: 2916714-2020-00396, 2916714-2020-00397, 2916714-2020-00399.

• Brand Name: VEGA PS GLIDING SURFACE T5 14MM
• Common Device Name: KNEE ENDOPROSTHESES
• Manufacturer (Section D): AESCULAP AG; po box 40; tuttlingen, 78501 ; GM 78501
• MDR Report Key: 11568811
• Report Number: 2916714-2020-00398
• Device Sequence Number: 17178435
• Product Code: JWH
• UDI-Device Identifier: 04046963811020
• UDI-Public: 4046963811020
• Combination Product (Y/N): N
• Initial Reporter State: TX
• 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): 03/25/2021
• Report Date (Section F): 03/25/2021

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: 05/01/2019
• Device Model Number: NX152
• Device Catalogue Number: NX152
• Device Lot Number: 52044932
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: Yes
• Distributor Facility Aware Date: 10/10/2018
• Event Location: Hospital
• Date Report to Manufacturer: 10/10/2018
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 03/25/2021
• 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: 03/25/2021