MAUDE Adverse Event Report: AESCULAP AG AS UNIVATION XF FEMUR CEMENTED F3 RM; KNEE ENDOPROSTHESES

Model Number	NO182Z
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)
Date of Event	10/15/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Reference code (b)(4).Device name as univation xf tibia cemented t2 rm.Serial number n/a.Batch number 52067851.Udi device identifier (b)(4).Udi production identifier (b)(4).Basic udi-di n/a.Unit of use udi-di (b)(4).Manufacturing date 2014-09-10.Ref.Code device name batch.(b)(4) as univation xf femur cemented f3 rm 52052589.(b)(4) univation f meniscal comp.T2 rm/lm 7mm 52067736.Investigation: no product at hand.Therefore an investigation 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 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 (univation loosening) a product safety case (psc) was initiated.
Event or Problem Description
It was reported that there was an issue with knee components.As a result of having the product implanted the patient has experienced knee pain, loosening and instability of the implant.The primary surgery occurred on (b)(6) 2014 and there was no reported revision surgery.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: no182z(femur cemented f3 rm).No157z(tibial cemented t2 rm).Nl471(pe insert t2 rm/lm 7 mm).Associated medwatches: 2916714-2020-00450.2916714-2020-00451.

• Brand Name: AS UNIVATION XF FEMUR CEMENTED F3 RM
• Common Device Name: KNEE ENDOPROSTHESES
• Manufacturer (Section D): AESCULAP AG; po box 40; tuttlingen, 78501 ; GM 78501
• MDR Report Key: 10655769
• Report Number: 2916714-2020-00449
• Device Sequence Number: 19442820
• Product Code: HRY
• UDI-Device Identifier: 04046964053597
• UDI-Public: 4046964053597
• Combination Product (Y/N): N
• Initial Reporter State: TX
• 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: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 10/09/2020

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
• Operator of Device: Health Professional
• Device Expiration Date: 06/01/2024
• Device Model Number: NO182Z
• Device Catalogue Number: NO182Z
• Device Lot Number: 52052589
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 10/15/2018
• Event Location: Hospital
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 10/09/2020
• 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