MAUDE Adverse Event Report: AESCULAP AG AS TIBIA EXTENSION STEM 12X52MM CEMENTED; KNEE ENDOPROSTHESES

Model Number	NX062Z
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); Swelling/ Edema (4577)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Reference code (b)(4).Device name as vega ps tibial plateau cemented t3.Serial number n/a.Batch number 51946471.Udi device identifier (b)(4).Udi production identifier (b)(4).Basic udi-di n/a.Unit of use udi-di (b)(4).Manufacturing date 21.06.2013.Ref.Code device name batch: nx043 patella 3-pegs p3 51955964.Nx030z as vega ps femoral component cemented f4r 51668821.Nx230 vega ps+ gliding surface t3/3+ 10mm 51906139.Nx062z as tibia extension stem 12x52mm cemented 51910897.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 2 similar complaints against the same lot number(s).Lot number 51955964: (b)(4).Explanation and rationale: no products available and therefore it is hardly possible to determine an exact conclusion and root cause.The exact cause cannot be determined.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 a vega knee components.As a result of having the product implanted the patient has experienced knee pain, swelling and loss of mobility which resulted in a revision surgery.The primary surgery occurred on (b)(6) 2013 and the revision surgery occurred on (b)(6) 2015.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 xc (b)(4).Involved components: nx043 (universal patella p3).Nx030z (ps femur cemented f4 rt).Nx230 (ps pe insert t3/t3+, 10mm).Nx055z (ps tibia cemented t3).Nx062z (tibial stem cemented 12x52mm).The cement used is unidentified.Associated medwatches: 2916714-2020-00286, 2916714-2020-00287, 2916714-2020-00288, 2916714-2020-00289.

• Brand Name: AS TIBIA EXTENSION STEM 12X52MM CEMENTED
• Common Device Name: KNEE ENDOPROSTHESES
• Manufacturer (Section D): AESCULAP AG; po box 40; tuttlingen, 78501 ; GM 78501
• MDR Report Key: 11012825
• Report Number: 2916714-2020-00290
• Device Sequence Number: 11661210
• Product Code: JWH
• UDI-Device Identifier: 04046963810559
• UDI-Public: 4046963810559
• Combination Product (Y/N): N
• Initial Reporter State: NC
• 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): 12/15/2020
• Report Date (Section F): 12/15/2020

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: 12/01/2022
• Device Model Number: NX062Z
• Device Catalogue Number: NX062Z
• Device Lot Number: 51910897
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: Yes
• Distributor Facility Aware Date: 04/09/2018
• Event Location: Hospital
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 12/15/2020
• 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: 12/15/2020