MAUDE Adverse Event Report: AESCULAP AG AS VEGA PS TIBIAL PLATEAU CEMENTED T3; KNEE ENDOPROSTHESES

Model Number NX055Z

Device Problems Compatibility Problem (2960); Material Integrity Problem (2978); Loosening of Implant Not Related to Bone-Ingrowth (4002)

Patient Problems Pain (1994); Ambulation Difficulties (2544)

Event Type  Injury  

Manufacturer Narrative

As of the date of this report the complaint product was not provided for investigation.Therefore, a thorough investigation is not possible.Batch history review: the device quality and manufacturing history records have been checked for the available lot number and were found to be according to our specifications valid at the time of production.Review of the complaint history revealed that there are 10 similar complaints against the same lot number(s).Conclusion and measures / preventive measures: based upon the investigation results a clear root cause conclusion cannot be drawn.There is no indication for a material-, manufacturing- or design-related failure.In the event that the complaint product will be provided for investigation in the future, an update of this report will be provided unsolicited.Based upon the investigations results there is capa is not necessary.

Event Description

It was reported that there was an issue with vega ps tibial plateau.According to the complaint description that as a result of having the product implanted, the patient has experienced pain, difficulty walking, and loosening of the implant.The primary surgery occurred on (b)(6) 2013 and the revision surgery occurred on (b)(6) 2018.Primary surgery: (b)(6) 2013.Revision surgery: (b)(6) 2018.A revision surgery was necessary.All available information has been provided at this time, if additional information becomes available the report will be updated accordingly.The adverse event is filed under aag reference (b)(4).Involved components: nx132 - vega ps gliding surface t3/3+ 14mm - lot 51949663, nn260p - plug f/tibial plateau - lot 51974495, nx013z - as vega ps femoral comp.Cemented f6n l - lot 51927043, nx044 - patella 3-pegs p4 - lot51911583, cement used is unidentified.

• Brand Name: AS VEGA PS TIBIAL PLATEAU CEMENTED T3
• Type of Device: KNEE ENDOPROSTHESES
• Manufacturer (Section D): AESCULAP AG; po box 40; tuttlingen, 78501 ; GM 78501
• Manufacturer (Section G): AESCULAP AG; po box 40; tuttlingen, 78501 ; GM 78501
• Manufacturer Contact: christian von der grün ; po box 40; tuttlingen, 78501 ; GM 78501
• MDR Report Key: 11342350
• MDR Text Key: 232337939
• Report Number: 9610612-2020-00261
• Device Sequence Number: 1
• Product Code: JWH
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K101281
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 02/18/2021

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
• Device Operator: Health Professional
• Device Expiration Date: 04/01/2023
• Device Model Number: NX055Z
• Device Catalogue Number: NX055Z
• Device Lot Number: 51938561
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 07/20/2018
• Initial Date FDA Received: 02/18/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 05/06/2013
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Treatment: NN260P - 51974495; NX013Z - 51927043; NX044 - 51911583; NX132 - 51949663
• Patient Outcome(s): Required Intervention