MAUDE Adverse Event Report: AESCULAP AG AS UNIVATION XF TIBIA CEMENTED T5 RM; KNEE ENDOPROSTHETICS

Model Number NO160Z

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

Patient Problem Failure of Implant (1924)

Event Date 04/17/2023

Event Type  Injury  

Manufacturer Narrative

Investigation results: aesculap ag did not receive a product for investigation.Therefore, investigation results are based on historical data analysis and batch history review.Batch history review: the device quality and manufacturing history records 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 no similar complaints against the same lot number.According to manufacturer's reporting evaluation in accordance with 21 cfr part 803, section 803.3, this event is considered reportable for the following reason - adverse event (not later than 30 days).The assessment for the reportability of this adverse event was based on the patient harm, revision.Conclusion/preventive measures: on basis of the available information as well as the investigation results a clear root cause conclusion cannot be drawn.There is no indication fo a material-, manufacturing- or design- related failure.In the event that the complaint sample will be provided for investigation in the future, an update of this report will be provided unsolicited.Based upon the investigation results, a capa is not necessary.Recall class 2 with the external reference number 88325 and internal number fsca 250 + 251 had been initiated 03/2021 and completed 04/2022.

Event Description

It was reported that there was an issue with the product no160z - as univation xf tibia cemented t5 rm.According to the complaint description, there was postoperative loosening of implants.The initial knee arthroplasty was performed on (b)(6) 2020; and the revision on (b)(6) 2023.Additional information was not provided nor available.Additional information regarding the patient is not available.The adverse event is filed under aesculap ag reference no.(b)(4) associated medwatch-reports: 9610612-2024-00016 (internal aesculap ag ref.No.(b)(4)) 9610612-2024-00017 (internal aesculap ag ref.No.(b)(4)) involved component: nl474/ univation f meniscal comp.T5 rm/lm 7mm - lot 52569652 (internal aesculap ag ref.No.(b)(4)).

• Brand Name: AS UNIVATION XF TIBIA CEMENTED T5 RM
• Type of Device: KNEE ENDOPROSTHETICS
• Manufacturer (Section D): AESCULAP AG; po box 40; tuttlingen, 78501 ; GM 78501
• Manufacturer (Section G): AESCULAP AG; po box 40; tuttlingen, 78501 ; GM 78501
• Manufacturer Contact: christian von der grün ; po box 40; tuttlingen, 78501 ; GM 78501
• MDR Report Key: 18741734
• MDR Text Key: 335780342
• Report Number: 9610612-2024-00017
• Device Sequence Number: 1
• Product Code: HRY
• Combination Product (y/n): N
• Reporter Country Code: GM
• PMA/PMN Number: K131167
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Company Representative
• Reporter Occupation: Other Health Care Professional
• Remedial Action: Recall
• Type of Report: Initial
• Report Date: 02/19/2024

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: NO160Z
• Device Catalogue Number: NO160Z
• Device Lot Number: 52568550
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 01/26/2024
• Initial Date FDA Received: 02/20/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 01/07/2020
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Treatment: NL474 - LOT 52569652
• Patient Outcome(s): Required Intervention
• Patient Age: 62 YR
• Patient Sex: Male