MAUDE Adverse Event Report: AESCULAP AG AS NUT F/FEMUR EXTENS.STEM ALL SZ.NEUTR.; KNEE ENDOPROSTHESES

Model Number	NR400Z
Medical Device Problem Code	Device Appears to Trigger Rejection (1524)
Health Effect - Clinical Code	Failure of Implant (1924)
Date of Event	04/25/2022
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported to aesculap inc.That a as nut f/femur extens.Stem all sz.Neutr.(part # nr400z) 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) - nr291z (2916714-2022-00056).(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).
Additional 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.
Additional Manufacturer Narrative
Additional information: b5 - patient harm updated, patient condition, planned revision date.B7 - patient medical history.Investigation results previously submitted.
Event or Problem Description
Update: the patient provided some additional information including the proposed revision date of (b)(6) 2023.She had been in contact with a newer surgeon in 2019, after the accident; the doctor at that time noted that the implant was "fine".Some recent unspecified diagnostic test results supposedly showed that the stem was broken or disconnected.She is now working with cedars-sinai orthopedic center.The adverse event is filed under aag reference (b)(4).Associated medwatch reports: 400554585 - nr191z (2916714-2022-00055), 400554587 - nr565z (2916714-2022-00056), 400554588 - nr565z (2916714-2022-00057), 400554589 - nr611m (2916714-2022-00058), 400554590 - nr071z (2916714-2022-00059), 400554591 - nr005z (2916714-2022-00060), 400554592 - nr400z (2916714-2022-00061).

• Brand Name: AS NUT F/FEMUR EXTENS.STEM ALL SZ.NEUTR.
• Common Device Name: KNEE ENDOPROSTHESES
• Manufacturer (Section D): AESCULAP AG; po box 40; tuttlingen, 78501 ; GM 78501
• MDR Report Key: 14456282
• Report Number: 2916714-2022-00062
• Device Sequence Number: 4436034
• Product Code: KRO
• UDI-Device Identifier: 04046963367732
• UDI-Public: 4046963367732
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2018
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Importer
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 04/18/2024
• Report Date (Section F): 05/19/2022

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 Model Number: NR400Z
• Device Catalogue Number: NR400Z
• Device Lot Number: 52428200
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Distributor Facility Aware Date: 04/25/2022
• Device Age: 4 YR
• Event Location: Hospital
• Date Report to Manufacturer: 04/25/2022
• Initial Date Received by Manufacturer: Not provided
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 05/20/2022
• Supplement Report FDA Received Date: 04/18/2024
• 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: Other; Required Intervention
• Patient Age: 70 YR
• Patient Sex: Female
• Date Report Sent to FDA: 05/19/2022