MAUDE Adverse Event Report: AESCULAP AG AS TIBIAL OBTURATOR D14MM; KNEE ENDOPROSTHESES

Model Number	NN264Z
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 nx056z, device name as vega ps tibial plateau cemented t3+, serial number n/a, batch number 52034818, manufacturing date 09.05.2014.Reference code device name corresponding internal notification number nx030z as vega ps femoral comp.Cemented f4r 400480664, nn264z as tibial obturator d14mm 400480665, nx043 patella 3-pegs p3 400480666, nx132 vega ps gliding surface t3/3+ 14mm 400480668.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 2 similar complaints against the same lot number(s).Lot number 52034818(registered as leading component).Lot number 51949663(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) 2015.According to the complainant, following the primary surgery, the patient experienced pain swelling, difficulty walking and loosening of the implant.After first revision surgery, patient continued to experience pain, swelling, difficulty walking and loosening of the implant, which resulted in a second revision surgery.The primary surgery occurred on (b)(6) 2015, with first revision in (b)(6) 2015, with another vega implant.The second revision surgery occurred on (b)(6) 2017, with an unidentified non-aesculap implant.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: nx030z (ps femur cemented f4 rt) nn264z (tibial obturator d14mm, l7mm) nx043 (universal patella p3) nx056z (ps tibia cemented t3+) nx132 (ps pe insert t3/t3+, 14mm) the components listed are related to the primary surgery.It is unknown exactly which components were replaced in the first and second revision surgery.Associated medwatches: 2916714-2020-00365, 2916714-2020-00367, 2916714-2020-00368 2916714-2020-00369.

• Brand Name: AS TIBIAL OBTURATOR D14MM
• Common Device Name: KNEE ENDOPROSTHESES
• Manufacturer (Section D): AESCULAP AG; po box 40; tuttlingen, 78501 ; GM 78501
• MDR Report Key: 11423435
• Report Number: 2916714-2020-00366
• Device Sequence Number: 3843624
• Product Code: JWH
• UDI-Device Identifier: 04046963124519
• UDI-Public: 4046963124519
• Combination Product (Y/N): N
• Initial Reporter State: AL
• 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): 03/05/2021
• Report Date (Section F): 03/05/2021

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 Model Number: NN264Z
• Device Catalogue Number: NN264Z
• 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: 03/05/2021
• 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: 03/05/2021