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

Model Number	NN260P
Medical Device Problem Code	Loosening of Implant Not Related to Bone-Ingrowth (4002)
Health Effect - Clinical Codes	Ambulation or Postural Difficulties (2544); Joint Laxity (4526); Implant Pain (4561)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Investigation results: 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 numbers 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 or Problem Description
It was reported that there was an issue with a knee implant system.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 (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 xc 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.Nx055z (ps tibia cemented t3); - lot 51938561.Nx044 - patella 3-pegs p4 - lot51911583.Cement used is unidentified.Associated medwatches: 2916714-2020-00307.2916714-2020-00309.2916714-2020-00310.2916714-2020-00311.

• Brand Name: PLUG F/TIBIAL PLATEAU
• Common Device Name: KNEE ENDOPROSTHESES
• Manufacturer (Section D): AESCULAP AG; po box 40; tuttlingen, 78501 ; GM 78501
• MDR Report Key: 11604250
• Report Number: 2916714-2020-00308
• Device Sequence Number: 11799879
• Product Code: JWH
• 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
• Device Implanted Year: 2013
• Device Explanted Year: 2018
• 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): 04/01/2021
• Report Date (Section F): 04/01/2021

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: 08/01/2018
• Device Model Number: NN260P
• Device Catalogue Number: NN260P
• Device Lot Number: 51974495
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: Yes
• Distributor Facility Aware Date: 07/20/2018
• Event Location: Hospital
• Date Report to Manufacturer: 07/20/2018
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 04/01/2021
• 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: 04/01/2021