MAUDE Adverse Event Report: AESCULAP AG AS FEMUR EXTENS.STEM 6° D12X77 CEMENTED; KNEE ENDOPROSTHESES

Model Number NR291Z

Device Problem Device Appears to Trigger Rejection (1524)

Patient Problem Failure of Implant (1924)

Event Date 04/25/2022

Event Type  Injury  

Manufacturer Narrative

Manufacturing site evaluation: the device was not returned to the manufacturer for physical evaluation.Additionally, no on-site evaluation of the unit was performed and no parts were returned for failure analysis.Therefore, the investigation was not able to confirm a device issue that could be associated with the reported event.Batch history review: the device history records (dhr) were reviewed for the reported lot number; the device was found to be within specification at the time of production.All device history records (dhr) are reviewed and released according to documented procedures and a device is not released if it does not meet requirements or is nonconforming.No similar complaints were identified against the same lot number with a similar reported event.Conclusion: a definitive conclusion regarding the complaint incident cannot be reached without a physical examination of the complaint device.There is no indication of a material defect, manufacturing failure, or design error on the basis of the device history record.For further investigation, examination of the complaint device is required.

Event Description

It was reported to aesculap ag that a as femur extens.Stem 6° d12x77 cemented (part # nr291z) was implanted during a left knee revision surgery performed on (b)(6) 2018.According to the complainant, post-operative bone deterioration of femur and tibia occurred.The complaint device has not been returned to the manufacturer for evaluation.An additional medical intervention was required.A revision in the future is likely, according to the patient.The malfunction is filed under aag reference (b)(4).Associated medwatch reports: 400554585 - nr191z (9610612-2022-00142).400554587 - nr565z (9610612-2022-00144).400554588 - nr565z (9610612-2022-00145).400554589 - nr611m (9610612-2022-00146).400554590 - nr071z (9610612-2022-00147).400554591 - nr005z (9610612-2022-00148).400554592 - nr400z (9610612-2022-00149).

• Brand Name: AS FEMUR EXTENS.STEM 6° D12X77 CEMENTED
• 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: 14456867
• MDR Text Key: 294768295
• Report Number: 9610612-2022-00143
• Device Sequence Number: 1
• Product Code: KRO
• UDI-Device Identifier: 04046963176464
• UDI-Public: 4046963176464
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K101815
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 05/19/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/20/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: NR291Z
• Device Catalogue Number: NR291Z
• Device Lot Number: 52046962
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 04/24/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 06/18/2014
• 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
• Patient Outcome(s): Other; Required Intervention
• Patient Age: 70 YR
• Patient Sex: Female