MAUDE Adverse Event Report: AESCULAP AG FEMUR EXTENS.STEM 6° D15X77MM CEMENTED; KNEE ENDOPROSTHETICS

Model Number	NR292K
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	Failure of Implant (1924)
Date of Event	08/11/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Manufacturing site evaluation: investigation on-going.Additional information / investigation results will be provided in a supplemental report.
Event or Problem Description
It was reported that a femur extens.Stem 6° d15x77mm cemented (nr292k) was implanted during a procedure performed on (b)(6) 2014.According to the complaint description, there was a revision surgery 7 years post surgery due to fracture of stem.A revision surgery was necessary.Additional information was not provided.Additional information has been requested but not yet received as of this report.The adverse event is filed under aag reference (b)(4).Involved components: nb017k - enduro femoral component cemented f1r - lot unknown.
Event or Problem Description
Additional information received: involved component nr871m.Revision surgery : (b)(6) 2021.Involved components nb017k - enduro femoral component cemented f1r - lot unknown.Nr871m - enduro meniscal component f1 12mm - lot 51788770.
Additional Manufacturer Narrative
Additional information received: updated b5 + d10: involved component.
Additional Manufacturer Narrative
Based upon investigation results, this event was re-evaluated and is considered no longer reportable due to change from leading to involved component - no malfunction or serious injury.The investigation results will be updated in the leading reference number: (b)(4).Associated medwatch report 9610612-2021-00783 (400525236 nb017k).

• Brand Name: FEMUR EXTENS.STEM 6° D15X77MM CEMENTED
• Common Device Name: KNEE ENDOPROSTHETICS
• 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: 12374225
• Report Number: 9610612-2021-00599
• Device Sequence Number: 17134892
• Product Code: JWH
• UDI-Device Identifier: 04046963339890
• UDI-Public: 4046963339890
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• PMA/510(K) Number: K083772
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2014
• Device Explanted Year: 2021
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 12/23/2021

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: 07/31/2024
• Device Model Number: NR292K
• Device Catalogue Number: NR292K
• Device Lot Number: 52061050
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/26/2021
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/05/2021
• Supplement Date Received by Manufacturer: 08/27/2021; 12/01/2021
• Initial Report FDA Received Date: 08/26/2021
• Supplement Report FDA Received Date: 09/21/2021; 12/23/2021
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/25/2014
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: NB017K - LOT UNKNOWN.; NB017K - LOT UNKNOWN.; NR871M - LOT 51788770.; NB017K - LOT UNKNOWN
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 84 YR
• Patient Sex: Female
• Patient Weight: 92 KG