MAUDE Adverse Event Report: AESCULAP AG AS TIBIA OFFSET STEM D18X92 CEMENTLESS; PROSTHESIS, KNEE

Model Number	NR178Z
Medical Device Problem Code	Patient-Device Incompatibility (2682)
Health Effect - Clinical Code	Failure of Implant (1924)
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported to aesculap inc.That an as tibia offset stem d18x92 cementless (part# nr178z) was implanted on (b)(6) 2021.According to the complainant the implant was too tight.Reportedly the patient is scheduled for a revision surgery on an unspecified date.Additional information has been requested but not yet provided.The adverse event is filed under aic reference (b)(4).2916714-2024-00151 (aic reference no.(b)(4)), 2916714-2024-00152 (aic reference no.(b)(4)), 2916714-2024-00153 (aic reference no.(b)(4)), 2916714-2024-00155 (aic reference no.(b)(4)), 2916714-2024-00156 (aic reference no.(b)(4)), 2916714-2024-00157 (aic reference no.(b)(4)), 2916714-2024-00158 (aic reference no.(b)(4)).
Additional Manufacturer Narrative
Investigation on-going.Should relevant additional information / investigation results become available, a supplemental medwatch report will be submitted.
Additional Manufacturer Narrative
Corrected information: d4 primary unique device identifier (udi) number.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.The device history records (dhr) were reviewed for the available 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.A definitive conclusion regarding the complaint incident cannot be reached without a physical examination of the complaint device.

• Brand Name: AS TIBIA OFFSET STEM D18X92 CEMENTLESS
• Common Device Name: PROSTHESIS, KNEE
• Manufacturer (Section D): AESCULAP AG; po box 40; tuttlingen, 78501 ; GM 78501
• MDR Report Key: 20446694
• Report Number: 2916714-2024-00154
• Device Sequence Number: 12863496
• Product Code: KRO
• UDI-Device Identifier: 04046963176334
• UDI-Public: (01)04046963176334(11)180525(17)280430(10)52432240
• Combination Product (Y/N): N
• Initial Reporter State: OK
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2021
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Importer
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 11/22/2024
• Report Date (Section F): 10/14/2024

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
• Operator of Device: Health Professional
• Device Model Number: NR178Z
• Device Catalogue Number: NR178Z
• Device Lot Number: 52432240
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Distributor Facility Aware Date: 09/20/2024
• Device Age: 6 YR
• Event Location: Hospital
• Date Report to Manufacturer: 09/20/2024
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: Not provided
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 10/14/2024
• Supplement Report FDA Received Date: 11/22/2024
• 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: Required Intervention
• Patient Sex: Unknown
• Date Report Sent to FDA: 10/14/2024