MAUDE Adverse Event Report: AESCULAP AG COLLECT.NO.QAS KNEE IMPLANTS ROTAT.HINGE; KNEE ENDOPROSTHETICS

Medical Device Problem Code	Loosening of Implant Not Related to Bone-Ingrowth (4002)
Health Effect - Clinical Codes	Failure of Implant (1924); Implant Pain (4561)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Investigation on-going.Should relevant additional information / investigation results become available, a supplemental medwatch report will be submitted.
Event or Problem Description
It was reported to aesculap inc.That an aesculap knee implant system (part # unknown) was implanted during a left total knee replacement procedure sometime in 2008.Reportedly the patient had underwent multiple revision procedures.A revision of the left total knee replacement was performed sometime in 2011.In 2013 the patient underwent a polyethylene exchange of the left knee sometime during (b)(6)2013.A complex revision to the left total knee replacement, the failed tc3 was converted to aesculap hinge was performed (b)(6)2015.A left total knee replacement was performed on (b)(6) 2017.The patient underwent a right total knee replacement on (b)(6) 2019.A revision left total knee arthroplasty for femoral component failure and loosening was performed on (b)(6) 2022.Reportedly the patient has developed debilitating symptoms consistent with tibial component loosening and required a revision procedure.
Additional Manufacturer Narrative
Investigation results: 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 not able to be reviewed as no lot number was made available.However, 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.Conclusion and measures / preventative measures: a definitive conclusion regarding the complaint incident cannot be reached without a physical examination of the complaint device.

• Brand Name: COLLECT.NO.QAS KNEE IMPLANTS ROTAT.HINGE
• Common Device Name: KNEE ENDOPROSTHETICS
• Manufacturer (Section D): AESCULAP AG; po box 40; tuttlingen, 78501 ; GM 78501
• MDR Report Key: 20619484
• Report Number: 2916714-2024-00178
• Device Sequence Number: 8792657
• Product Code: JWH
• UDI-Device Identifier: 04046964451751
• UDI-Public: (01)04046964451751
• Combination Product (Y/N): N
• Initial Reporter State: GA
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2022
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Importer
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 01/02/2025
• Report Date (Section F): 11/06/2024

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
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Distributor Facility Aware Date: 10/11/2024
• Event Location: Hospital
• Date Report to Manufacturer: 10/11/2024
• Initial Date Received by Manufacturer: Not provided
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 11/06/2024
• Supplement Report FDA Received Date: 01/02/2025
• 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 Age: 77 YR
• Patient Sex: Female
• Date Report Sent to FDA: 11/06/2024