MAUDE Adverse Event Report: AESCULAP AG AS TIBIA EXTENSION STEM 14X52MM CEMENTED; KNEE ENDOPROSTHETICS

Model Number NX063Z

Device Problem Loose or Intermittent Connection (1371)

Patient Problem Pain (1994)

Event Date 04/09/2018

Event Type  Injury  

Manufacturer Narrative

Device reference code: (b)(4).Device name: as vega ps tibial plateau, cemented t3.Serial number: n/a.Batch number: 51904336.Udi device identifier: (b)(4).Udi production identifier: (b)(4).Basic udi-di: n/a.Unit of use udi-di: (b)(4).Manufacturing date: 2012-02-07.Ref.Code device name batch: nx013z as vega ps femoral comp.Cemented f6n l 51837867, nx063z as tibia extension stem 14x52mm cemented 51879136, nx130 vega ps gliding surface t3/3+ 10mm 51921828, nx043 patella 3-pegs p3 51915392, nn260p plug f/tibial plateau 51974495.Investigation: no product at hand.Therefore an investigation at the product is 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 7 similar complaints against the same lot number: 51904336.(1 as involved component).There are 2 similar complaints against the same lot number: 51915392.(all as involved components).There are 6 similar complaints against the same lot number: 51974495.(all as involved components).Explanation and rationale: 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 Description

It was reported that there was an issue with as vega knee.As a result of having the product implanted, the patient has experienced knee pain and loosening of the implant.The primary surgery occurred on (b)(6) 2014 and there was no reported 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).Associated medwatches: 2916714-2020-00390, 2916714-2020-00391, 2916714-2020-00393, 2916714-2020-00394, 2916714-2020-00395.Involved components: nx013z (ps femur cemented f6n lt), nx055z (ps tibia cemented t3), nx063z (tibial stem cemented 14x52mm), nx130 (ps pe insert t3/t3+, 10mm), nx043 (universal patella p3), nn260p (peek plug f/tibia).The cement used is unidentified.

• Brand Name: AS TIBIA EXTENSION STEM 14X52MM CEMENTED
• Type of Device: KNEE ENDOPROSTHETICS
• Manufacturer (Section D): AESCULAP AG; po box 40; tuttlingen, 78501 ; GM 78501
• MDR Report Key: 10587662
• MDR Text Key: 209002041
• Report Number: 2916714-2020-00392
• Device Sequence Number: 1
• Product Code: HRY
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Distributor
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 09/25/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/25/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: NX063Z
• Device Catalogue Number: NX063Z
• Device Lot Number: 51879136
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 08/11/2018
• Event Location: Hospital
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Other