MAUDE Adverse Event Report: AESCULAP AG PATELLA 3-PEGS P4; KNEE ENDOPROSTHESES

Model Number	NX044
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); Swelling/ Edema (4577)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Investigation results: reference code nx055z, device name as vega ps tibial plateau cemented t3, serial number n/a, batch number 51904336, manufacturing date 07.12.2012.Reference code device name corresponding internal notification number nx013z as vega ps femoral comp.Cemented f6n l 400480659, nn260p plug f/tibial plateau 400480661, nx044 patella 3-pegs p4 400480662, nx130 vega ps gliding surface t3/3+ 10mm 400480663.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 11 similar complaints against the same lot number(s).Lot number 51884096 (registered as involved component), lot number 51904336 (registered as leading components), lot number 51904876 (registered as involved components), lot number 51911583 (registered as involved components), lot number 51910898 (registered as involved component).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) 2013(left) (b)(6) 2013(right).According to the complainant, following the primary surgery, the patient experienced pain swelling, difficulty walking and loosening of the implant, which resulted in a left knee revision surgery.The patient underwent a revision surgery on (b)(6) 2015 left knee.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: nx013z (ps femur cemented f6n lt), nx055z (ps tibia cemented t3), nn260p (peek plug f/ tibia), nx044 (universal patella p4), nx130 (ps pe insert t3/t3+, 10mm).Associated medwatches: 2916714-2020-00355, 2916714-2020-00356, 2916714-2020-00357, 2916714-2020-00359.

• Brand Name: PATELLA 3-PEGS P4
• Common Device Name: KNEE ENDOPROSTHESES
• Manufacturer (Section D): AESCULAP AG; po box 40; tuttlingen, 78501 ; GM 78501
• MDR Report Key: 11416170
• Report Number: 2916714-2020-00358
• Device Sequence Number: 17051830
• Product Code: JWH
• UDI-Device Identifier: 04046963810306
• UDI-Public: 4046963810306
• 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): 03/04/2021
• Report Date (Section F): 03/04/2021

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: 12/01/2017
• Device Model Number: NX044
• Device Catalogue Number: NX044
• Device Lot Number: 51911583
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: Yes
• Distributor Facility Aware Date: 07/20/2018
• Device Age: 5 YR
• Event Location: Hospital
• Date Report to Manufacturer: 07/20/2018
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 03/04/2021
• 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: 03/04/2021