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  

Event Description

It was reported to aesculap inc.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.According to the patient , a revision surgery in the future is likely.Additional information was not provided.The malfunction is filed under aic reference (b)(4).Associated medwatch reports: (b)(4) - nr191z (2916714-2022-00055), (b)(4) - nr565z (2916714-2022-00057), (b)(4) - nr565z (2916714-2022-00058), (b)(4) - nr611m (2916714-2022-00059), (b)(4) - nr071z (2916714-2022-00060), (b)(4) - nr005z (2916714-2022-00061), (b)(4) - nr400z (2916714-2022-00062).

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.

• 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
• MDR Report Key: 14456608
• MDR Text Key: 293499611
• Report Number: 2916714-2022-00056
• Device Sequence Number: 1
• Product Code: KRO
• UDI-Device Identifier: 04046963176464
• UDI-Public: 4046963176464
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Distributor
• 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
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 05/19/2022
• Distributor Facility Aware Date: 04/25/2022
• Device Age: 8 YR
• Event Location: Hospital
• Date Report to Manufacturer: 04/25/2022
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention; Other
• Patient Age: 70 YR
• Patient Sex: Female