MAUDE Adverse Event Report: AESCULAP AG PATELLA 3-PEGS P3; KNEE ENDOPROSTHESES

Model Number	NX043
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Pain (1994); Ambulation or Postural Difficulties (2544); Swelling/ Edema (4577)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Reference code nx055z.Device name as vega ps tibial plateau cemented t3, serial number n/a, batch number 52034569, udi device identifier (b)(4), udi production identifier (b)(4), basic udi-di n/a, unit of use udi-di (b)(4), manufacturing date 28.04.2014.Ref.Code device name batch: nx011z as vega ps femoral comp.Cemented f5n l 52066985.Nx043 patella 3-pegs p3 unknown.Nx130 vega ps gliding surface t3/3+ 10mm unknown.Nn261z as tibial obturator d12mm unknown.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 no similar complaints against the same lot number(s) with this error pattern.Explanation and rationale: unfortunately due to a lack of data and without the products we cannot determine the exact root cause for the mentioned deviation.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 pain, swelling in left knee and difficulty walking.The primary surgery occurred on (b)(6) 2015 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).Involved components: nx011z(ps femur cemented f5n lt), nx043 (universal patella p3), nx055z (ps tibia cemented t3), nx130 (ps pe insert t3/t3+, 10mm), nn261z(tibial obturator d12mm, l7mm).The cement used is unidentified.Associated medwatches: 2916714-2020-00249, 2916714-2020-00251, 2916714-2020-00252, 2916714-2020-00253.

• Brand Name: PATELLA 3-PEGS P3
• Common Device Name: KNEE ENDOPROSTHESES
• Manufacturer (Section D): AESCULAP AG; po box 40; tuttlingen, 78501 ; GM 78501
• MDR Report Key: 11014061
• Report Number: 2916714-2020-00250
• Device Sequence Number: 14357024
• Product Code: JWH
• UDI-Device Identifier: 04046963810290
• UDI-Public: 4046963810290
• Combination Product (Y/N): N
• Initial Reporter State: LA
• 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?: No
• Operator of Device: Health Professional
• Device Model Number: NX043
• Device Catalogue Number: NX043
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: Yes
• Distributor Facility Aware Date: 10/27/2017
• 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: Other
• Date Report Sent to FDA: 12/15/2020