MAUDE Adverse Event Report: AESCULAP AG ENDURO MENISCAL COMPONENT F2 10MM; KNEE ENDOPROSTHESES

Model Number	NR880M
Medical Device Problem Code	Loosening of Implant Not Related to Bone-Ingrowth (4002)
Health Effect - Clinical Code	Failure of Implant (1924)
Date of Event	05/06/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Manufacturer evaluation: 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 (b)(4) that a enduro meniscal component f2 10mm (part # nr880m) was used during a procedure performed on (b)(6) 2010.According to the complainant, the implant loosened 5 years post surgery.De-coupling of axis of an enduro prosthesis (implanted 2010).Already in 2016 the coupling loosened and was revised with a f2 10mm pe.The patient underwent a revision surgery on (b)(6) 2021, and the prosthesis was secured with a new lock nut.The complaint device was returned to the manufacturer for evaluation.No patient complications were reported as a result of the revision surgery.Although requested, additional information has not been made available.The adverse event is filed under aag reference (b)(4).
Additional Manufacturer Narrative
Corrected date - b5 (changed from leading material to involved component), h6 (component code).Based upon investigation results, this event was re-evaluated and is considered no longer reportable due to the change from leading material to involved component.Manufacturing site evaluation: investigation results: visual investigation: the components have been examined visually and microscopically with the digital microscope.The external screw thread of the rotation axis shows visible damages/ material abrasions on the whole circumference.The last inner thread of the rotation axis locknut is damaged.Furthermore the taper of the rotation axis shows little imprints.There are little metal inclusions on the gliding surface as well as on the bottom side of the meniscal component.The locking ring and the bearing for rotation axis show no significant/unusual damages.Batch history review: the device quality and manufacturing history records have been checked for the available lot number and were found to be according to our specifications valid at the time of production.Review of the complaint history revealed that no similar complaints have been filed against products from this batch number.The review of risk assessment revealed that the overall risk level (severity 4(5) probability of occurrence2(5)) according to din en iso 14971 is still acceptable.Conclusion and measures / preventive measures: based upon the investigation results a clear root cause conclusion cannot be drawn.There is no indication for a material-, manufacturing- or design-related failure.The thread can only loosen when the taper connection has not been connected correctly.Based upon the investigations results a capa is not necessary.
Event or Problem Description
Correction/additional information: nr880m - enduro meniscal component f2 10mm - lot 52223023 was changed from leading material to involved component.Associated medwatch reports: 9610612-2021-00416, 9610612-2021-00440.

• Brand Name: ENDURO MENISCAL COMPONENT F2 10MM
• Common Device Name: 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: 11938276
• Report Number: 9610612-2021-00416
• Device Sequence Number: 4268513
• Product Code: KRO
• UDI-Device Identifier: 04046964010286
• UDI-Public: 4046964010286
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• PMA/510(K) Number: K101815
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2010
• Device Explanted Year: 2021
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 11/04/2021

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 Expiration Date: 02/28/2021
• Device Model Number: NR880M
• Device Catalogue Number: NR880M
• Device Lot Number: 52223023
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/18/2021
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/06/2021
• Supplement Date Received by Manufacturer: 10/05/2021
• Initial Report FDA Received Date: 06/04/2021
• Supplement Report FDA Received Date: 11/06/2021
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/09/2016
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Male