MAUDE Adverse Event Report: AESCULAP AG PATELLA 3-PEGS P2; KNEE ENDOPROSTHESES

Model Number	NX042
Medical Device Problem Code	Patient Device Interaction Problem (4001)
Health Effect - Clinical Codes	Ambulation or Postural Difficulties (2544); Implant Pain (4561)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Investigation results: reference code (b)(4), device name as vega ps tibial plateau cemented t2, serial number n/a, batch number 51964150, manufacturing date 19.09.2013.Reference code device name corresponding internal notification number nn260p plug f/tibial plateau 400479807, nx042 patella 3-pegs p2 400479809, nx031z as vega ps femoral comp cemented f5n r 400479810, nx121 vega ps gliding surface t2/2+ 12mm 400479811.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: 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 (implant loosening) a product safety case (psc) was initiated.
Event or Problem Description
It was reported to aesculap inc.That a vega knee implant system was implanted during a primary surgery performed on (b)(6) 2014.According to the complainant, following the primary surgery, the patient experienced pain and difficulty in walking of the implant.The patient underwent a revision surgery occurred on (b)(6) 2015.The complaint device was not available to be returned to the manufacturer for evaluation.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: nn260p (peek plug f/ tibia), nx053z (ps tibia cemented t2), nx042 (universal patella p2), nx031z (ps femur cemented f5n rt), nx121 (ps pe insert t2/t2+, 12mm).The cement used is unidentified.Associated medwatches: 2916714-2020-00319, 2916714-2020-00320, 2916714-2020-00322, 2916714-2020-00323.

• Brand Name: PATELLA 3-PEGS P2
• Common Device Name: KNEE ENDOPROSTHESES
• Manufacturer (Section D): AESCULAP AG; po box 40; tuttlingen, 78501 ; GM 78501
• MDR Report Key: 11440320
• Report Number: 2916714-2020-00321
• Device Sequence Number: 4610752
• Product Code: JWH
• UDI-Device Identifier: 04046963810283
• UDI-Public: 4046963810283
• Combination Product (Y/N): N
• Initial Reporter State: FL
• 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): 03/08/2021
• Report Date (Section F): 03/08/2021

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: NX042
• Device Catalogue Number: NX042
• Device Lot Number: 51965405
• 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: 03/08/2021
• 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: 03/08/2021