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

Model Number	NX042
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)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Investigation results: reference code: nx053z, device name: as vega ps tibial plateau cemented t2, serial number: n/a, batch number: 51954907, manufacturing date: 08.07.2013.Ae-qas-k521-99 collect.No.Qas knee impl.Misc./unknown reference code: nx009z, device name: as vega ps femoral comp.Cemented f4n l corresponding internal notification number: (b)(4).Reference code: nn260p, device name: plug f/tibial plateau, corresponding internal notification number: (b)(4).Reference code: nx042 , device name: patella 3-pegs p2, corresponding internal notification number: (b)(4).Device name: ae-qas-k521-99 collect.No.Qas knee impl.Misc./unknown, corresponding internal notification number: (b)(4).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 12 similar complaints against the same lot number(s).Lot number: 51963203: (b)(4).Lot number: 51954907: (b)(4).Lot number: 51974495: (b)(4).Explanation and rationale: unfortunately due to a lack of data and without the product we cannot determine the exact root cause for the mentioned deviation.Corrective action: for this topic (implant loosening) a product safety case (psc) was initiated.
Event or Problem Description
It was reported that there was an issue with a knee implant system.It was reported on (b)(6) 2017, that as a result of having the product implanted, the patient has experienced knee pain, difficulty walking and loosening of the implant which resulted in a revision surgery.The primary surgery occurred on (b)(6) 2014 and the revision surgery occurred on (b)(6) 2017.All available information has been provided at this time, if additional information becomes available the complaint will be updated accordingly.The adverse event is filed under aag reference (b)(4).Involved components: nx009z (ps femur cemented f4n lt).Nx053z (ps tibia cemented t2).Nn260p (peek plug f/tibia).Nx042 (universal patella p2).Ae-qas-k521-99(collect.No.Qas knee impl.Misc./unknown).Associated medwatches: 2916714-2020-00384, 2916714-2020-00385, 2916714-2020-00386, 2916714-2020-00388.

• 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: 11641008
• Report Number: 2916714-2020-00387
• Device Sequence Number: 3149907
• Product Code: JWH
• UDI-Device Identifier: 04046963810283
• UDI-Public: 4046963810283
• Combination Product (Y/N): N
• Initial Reporter State: LA
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2014
• Device Explanted Year: 2017
• 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): 04/09/2021
• Report Date (Section F): 04/09/2021

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: 03/01/2018
• Device Model Number: NX042
• Device Catalogue Number: NX042
• Device Lot Number: 51937514
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: Yes
• Distributor Facility Aware Date: 10/27/2017
• Event Location: Hospital
• Date Report to Manufacturer: 10/27/2017
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 04/09/2021
• 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: 04/09/2021