MAUDE Adverse Event Report: AESCULAP AG AS UNIVATION XF FEMUR CEMENTED F4 LM; KNEE ENDOPROSTHESES

Model Number	NO188Z
Medical Device Problem Code	Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	Insufficient Information (4580)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Reference code no165z, device name as univation xf tibia cemented t4, lm, serial number n/a, batch number 52231095, udi device identifier (b)(4), udi production identifier (b)(4), basic udi-di n/a, unit of use udi-di (b)(4), manufacturing date 2016-04-20.Ref.Code device name batch nr.No188z, as univation xf femur cemented f4 lm, 52235667.Nl473, univation f meniscal comp.T4 rm/lm 7mm, 52232908.Nx044, patella 3-pegs, p4 52316618.Np583r, threaded pin headless 3.2mm x 63mm, unknown.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 2 similar complaints against the same lot number 52232908.(all registered as involved component).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 (vega 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 unknown claims, but it is known that it resulted in a revision surgery.The primary surgery occurred on (b)(6) 2016 and the revision surgery occurred on (b)(6) 2017.Cement used: zimmer palacos cement 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: no165z (tibial cemented t4 lm), no188z (femur cemented f4 lm), nl473 (pe insert t4 rm/lm 7mm), nx044 (universal patella p4), np583r (threaded pin, headless 3.2mmx63mm).Associated medwatches: 2916714-2020-00570, 2916714-2020-00572, 2916714-2020-00573, 2916714-2020-00574.

• Brand Name: AS UNIVATION XF FEMUR CEMENTED F4 LM
• Common Device Name: KNEE ENDOPROSTHESES
• Manufacturer (Section D): AESCULAP AG; po box 40; tuttlingen, 78501 ; GM 78501
• MDR Report Key: 10813334
• Report Number: 2916714-2020-00571
• Device Sequence Number: 14488679
• Product Code: JWH
• UDI-Device Identifier: 04046964053658
• UDI-Public: 4046964053658
• 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): 11/09/2020

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: 03/31/2026
• Device Model Number: NO188Z
• Device Catalogue Number: NO188Z
• Device Lot Number: 52235667
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 07/18/2018
• Event Location: Hospital
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 11/09/2020
• 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