MAUDE Adverse Event Report: AESCULAP AG AS COLUMBUS REV F FEMUR CEMENTED F6R; KNEE ENDOPROSTHETICS

Model Number	NR016Z
Medical Device Problem Code	Device Ingredient or Reagent Problem (2910)
Health Effect - Clinical Codes	Alteration in Body Temperature (4568); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/03/2023
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Manufacturing site 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 that there was an issue with nr016z - as columbus rev f femur cemented f6r.According to the complainant, the femur implant had white particles all over the first sterile package.When opening the last sterile barrier, which final femur implant resides, it was noticed that barrier was already open.There was no backup femur implant so the surgeon had to downsize the femur.This event occured during a total knee revision procedure.The second implant, for femoral augment, had black material in the sterile packaging.After doing some investigating, both of these items were found to be completely open.One of them even had the scan code removed from the package.These items were removed by the tech that checked the set in and scrapped them.There was no red tag on the items either.Additional information was received which revealed that the surgeon had to down size femur to accommodate next size implant.Reportedly, this was done by taking more bone leading to a longer surgery.This event prolonged the surgery with one hour.An additional medical intervention was necessary.The adverse event is filed under aag reference (b)(4).Associated medwatch-reports: 9610612-2023-00088 (400596987 - nr566z).
Additional Manufacturer Narrative
Additional information/correction: h6 codes - updated.Investigation results: an investigation method could not be applied, because the product/packaging was not available for investigation.Device history review: the device quality and manufacturing history records have been checked for all leading device(s) lot numbers and the products found to be according to our specification valid at the time of production.There are 0 similar complaints against the same lot number root cause cannot be finally concluded.Therefore the root cause specific risk cannot be identified.The potential risk determined during initial vigilance evaluation remains valid.Conclusion and preventive measures: on the basis of the current information and without a product for investigation, a clear conclusion cannot be drawn.The device history records have been checked and no abnormalities could be observed.There are no further complaints from products with the same batches registered in our system.Therefore we exclude a systematical error.Based upon the investigation results, a capa is not necessary.
Event or Problem Description
Associated medwatch-reports: 9610612-2023-00087 ((b)(4) - nr016z).9610612-2023-00088 ((b)(4) - nr566z).

• Brand Name: AS COLUMBUS REV F FEMUR CEMENTED F6R
• 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 gruen ; po box 40; tuttlingen, 78501 ; GM 78501
• MDR Report Key: 16856196
• Report Number: 9610612-2023-00087
• Device Sequence Number: 7648350
• Product Code: JWH
• UDI-Device Identifier: 04046963175382
• UDI-Public: 4046963175382
• Combination Product (Y/N): N
• Initial Reporter State: NC
• Initial Reporter Country: US
• PMA/510(K) Number: K083772
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 10/30/2023

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: NR016Z
• Device Catalogue Number: NR016Z
• Device Lot Number: 52357748
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/03/2023
• Supplement Date Received by Manufacturer: 10/20/2023
• Initial Report FDA Received Date: 05/02/2023
• Supplement Report FDA Received Date: 10/30/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 09/04/2017
• 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: Unknown