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

Model Number	NX043
Medical Device Problem Code	Loosening of Implant Not Related to Bone-Ingrowth (4002)
Health Effect - Clinical Codes	Pain (1994); Joint Laxity (4526)
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 51908811, manufacturing date 14.01.2013.Reference code device name corresponding internal notification number: nx031z as vega ps femoral comp.Cemented f5n r 400480438, nn260p plug f/tibial plateau 400480440, nx043 patella 3-pegs p3 400480441, nx123 vega ps gliding surface t2/2+ 16mm 400480442.Investigation: no products are available.Therefore a failure description 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 leading device(s) lot numbers and the products found to be according to our specification valid at the time of production.There are 3 similar complaints against the same lot number(s).Lot number 51959433 (registered as involved component), lot number 51924244 (registered as involved components).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 (mplant loosening) a product safety case (psc) was initiated.
Event or Problem Description
It was reported that there was an issue with a knee components.It was reported on (b)(6) 2018, that as a result of having the product implanted the patient has experienced pain, difficulty walking and loosening of the implant, which resulted in a revision surgery.The primary surgery occurred on (b)(6) 2013 and the revision surgery occurred on (b)(6) 2018.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 xc (b)(4).Involved components: nx031z (ps femur cemented f5n rt), nx053z (ps tibia cemented t2), nn260p (peek plug f/ tibia), nx043 (universal patella p3), nx123 (ps pe insert t2/t2+, 16mm).Associated medwatches: 2916714-2020-00349, 2916714-2020-00350, 2916714-2020-00351, 2916714-2020-00353.

• 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: 11348688
• Report Number: 2916714-2020-00352
• Device Sequence Number: 17170551
• Product Code: JWH
• UDI-Device Identifier: 04046963810290
• UDI-Public: 4046963810290
• 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): 02/19/2021
• Report Date (Section F): 02/19/2021

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: 02/01/2018
• Device Model Number: NX043
• Device Catalogue Number: NX043
• Device Lot Number: 51924244
• 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: 02/19/2021
• 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: 02/19/2021