MAUDE Adverse Event Report: AESCULAP AG UNIVATION F MENISCAL COMP.T3 RM/LM 8MM; KNEE ENDOPROSTHESES

Model Number NL478

Device Problem Insufficient Heating (1287)

Patient Problems Failure of Implant (1924); Insufficient Information (4580)

Event Type  Injury  

Event Description

It was reported that there was an issue with the product nl478 - univation f meniscal comp.T3 rm/lm 8mm.According to the complaint description, the patient underwent revision due to postoperative inlay wear.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.No further data was provided nor available.The adverse event is filed under aesculap ag reference no.(b)(4) (400641041).

Manufacturer Narrative

Manufacturing site evaluation: investigation on-going.Additional information / investigation results will be provided in a supplemental report.

Manufacturer Narrative

Additional information: b5 - update.D10 - involved components added.H3 - yes, evaluation.H6 - codes updated.Investigation results: the provided meniscal component shows massive visible damages like material deformations /delaminations scratches and imprints on the gliding surface.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 eportable 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 the basis of the current information a clear conclusion cannot be drawn.The provided x-ray figures give also no clear hint regarding the root cause for the massive signs of wear of the meniscal component.There is no indication for a material defect or manufacturing failure on the basis of the device history records.Based upon the investigation results, a capa is not required.

Event Description

Update: according to the sales representative, the wear of the inlay was detected during an arthroscopy procedure.The femoral- as well as the tibial component were not removed; only the meniscal component was replaced.Involved components: no183z/ as univation xf femur cemented f4 rm - lot 52115487 (internal aesculap ag reference no.(b)(4)).No158z/ as univation xf tibia cemented t3 rm - lot 52119260 (internal aesculap ag reference no.(b)(4)).

• Brand Name: UNIVATION F MENISCAL COMP.T3 RM/LM 8MM
• Type of Device: KNEE ENDOPROSTHESES
• 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: 18726915
• MDR Text Key: 335713985
• Report Number: 9610612-2024-00021
• Device Sequence Number: 1
• Product Code: HRY
• Combination Product (y/n): N
• Reporter Country Code: GM
• PMA/PMN Number: K081293
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 04/03/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/16/2024
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 12/31/2019
• Device Model Number: NL478
• Device Catalogue Number: NL478
• Device Lot Number: 52109154
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/31/2024
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/06/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/02/2015
• 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: NO158Z - LOT 52119260; NO183Z - LOT 52115487
• Patient Outcome(s): Required Intervention