MAUDE Adverse Event Report: AESCULAP AG AS VEGA PS FEMORAL COMP.CEMENTED F3R; KNEE ENDOPROSTHETICS

Model Number	NX028Z
Medical Device Problem Code	Loosening of Implant Not Related to Bone-Ingrowth (4002)
Health Effect - Clinical Codes	Ambulation or Postural Difficulties (2544); Implant Pain (4561); Swelling/ Edema (4577)
Date of Event	06/03/2016
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Manufacturing site evaluation: no product at hand.Therefore a failure description at the device is not possible.Investigation no product at hand.Therefore an investigation at the product is not possible.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, conclusion and root cause 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
It was reported that there was an issue with nx028z - as vega ps femoral comp.Cemented f3r.It was reported on 12apr2019, that as a result of having the product implanted, the patient has experienced knee pain, difficulty walking, swelling, and loosening and instability of the implant, which resulted in a revision surgery.The primary surgery occurred on (b)(6) 2015, and the revision surgery occurred on (b)(6) 2016.All available information has been provided at this time, if additional information becomes available the complaint will be updated accordingly.The adverse event is filed under aag reference (b)(4).Cement used: unidentified.

• Brand Name: AS VEGA PS FEMORAL COMP.CEMENTED F3R
• Common Device Name: KNEE ENDOPROSTHETICS
• Manufacturer (Section D): AESCULAP AG; po box 40; tuttlingen, 78501 ; GM 78501
• MDR Report Key: 11685986
• Report Number: 9610612-2021-00221
• Device Sequence Number: 3015026
• Product Code: JWH
• UDI-Device Identifier: 04046963810108
• UDI-Public: 4046963810108
• Combination Product (Y/N): N
• Initial Reporter State: NC
• Initial Reporter Country: US
• PMA/510(K) Number: K101281
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2015
• Device Explanted Year: 2016
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 04/19/2021

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: 08/01/2023
• Device Model Number: NX028Z
• Device Catalogue Number: NX028Z
• Device Lot Number: 51964475
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/03/2016
• Initial Report FDA Received Date: 04/19/2021
• 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