MAUDE Adverse Event Report: AESCULAP AG AS TIBIAL OBTURATOR D12MM; KNEE ENDOPROSTHETICS

Model Number NN261Z

Device Problem Loosening of Implant Not Related to Bone-Ingrowth (4002)

Patient Problems Pain (1994); Ambulation Difficulties (2544); Swelling/ Edema (4577)

Event Type  Injury  

Manufacturer Narrative

Reference code (b)(4).Device name as vega ps tibial plateau.Cemented t2.Serial number n/a.Batch number 51983927.Udi device identifier (b)(4).Udi production identifier (b)(4).Basic udi-di n/a.Unit of use udi-di (b)(4).Manufacturing date 2013-10-25.Ref.Code device name batch.Nx011z as vega ps femoral comp.Cemented f5n l 51979353.Nx043 patella 3-pegs p3 51971042.Nn261z as tibial obturator d12mm unknown.Investigation.No product at hand.Therefore an investigation at the device 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 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.In the light of the little information received and due the circumstance that we did not received the complained devices it is not possible to determine a root cause for the mentioned failure.Corrective action.For this topic (loosening) a product safety case (psc) was initiated.

Event Description

It was reported that there was an issue with as vega knee.It was reported that as a result of having the product implanted, the patient has experienced knee pain, swellling, difficulty walking, and loosening and instability of the device.The primary procedure occurred on (b)(6) 2014, and the revision was performed on (b)(6) 2018.All available information has been provided at this time, if additional information becomes available the complaint will be updated accordingly.Involved components: nx011z (ps femur cemented f5n lt).Nx053z (ps tibia cemented t2).Nx043 (universal patella p3).Nn261z (tibial obturator d12mm, l7mm).The cement used was unspecified.The adverse event / malfunction is filed under reference (b)(4).Associated medwatches: 2916714-2020-00471.2916714-2020-00472.2916714-2020-00473.

• Brand Name: AS TIBIAL OBTURATOR D12MM
• Type of Device: KNEE ENDOPROSTHETICS
• Manufacturer (Section D): AESCULAP AG; po box 40; tuttlingen, 78501 ; GM 78501
• MDR Report Key: 10684339
• MDR Text Key: 211665885
• Report Number: 2916714-2020-00474
• Device Sequence Number: 1
• Product Code: HRY
• UDI-Device Identifier: 04046963124502
• UDI-Public: 4046963124502
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Distributor
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 10/15/2020

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
• Device Operator: Health Professional
• Device Model Number: NN261Z
• Device Catalogue Number: NN261Z
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 10/15/2020
• Distributor Facility Aware Date: 10/15/2018
• Event Location: Hospital
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 10/15/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention