MAUDE Adverse Event Report: AESCULAP AG COLUMBUS REV F MC GLID.SURF.T2/2+ 18MM; KNEE ENDOPROSTHESES

Model Number	NR124M
Medical Device Problem Codes	Device Dislodged or Dislocated (2923); Manufacturing, Packaging or Shipping Problem (2975)
Health Effect - Clinical Codes	Failure of Implant (1924); Joint Dislocation (2374)
Date of Event	12/19/2022
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that there was an issue with nr124m - columbus rev f mc glid.Surf.T2/2+ 18mm.According to the complaint description, the joint dislocated postoperatively on (b)(6) 2022.A closed reduction was planned and performed on 20dec2022; the t2 18 mc mm poly was replaced with t2 20mm hc poly.A revision was necessary.Additional information was not provided.The adverse event is filed under aag reference (b)(4).
Additional Manufacturer Narrative
Manufacturing site evaluation: investigation on-going.Should relevant additional information / investigation results become available, a supplemental medwatch report will be submitted.
Additional Manufacturer Narrative
Investigation: an investigation method could not be applied, because products were not provided to us for investigation.No products at hand, therefore a failure description of the product is not possible.Batch history review: the device quality and manufacturing history records (dhr) have been checked for this product and found to be according to our specification valid at the time of production.There are no similar complaints against the same lot number.Explanation, rationale, conclusion and root cause: on the basis of the current information and due to the circumstance that we did not receive the complained devices for investigation, it is not possible to determine a definitive root cause for the mentioned failure.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.Based on the investigation results, a capa is not required.

• Brand Name: COLUMBUS REV F MC GLID.SURF.T2/2+ 18MM
• 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: 16160898
• Report Number: 9610612-2022-00384
• Device Sequence Number: 7052454
• Product Code: JWH
• UDI-Device Identifier: 04046964009464
• UDI-Public: 4046964009464
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: K122985
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Explanted Year: 2022
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date (Section B): 02/16/2023

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 Expiration Date: 05/31/2024
• Device Model Number: NR124M
• Device Catalogue Number: NR124M
• Device Lot Number: 52520879
• 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: 12/19/2022
• Supplement Date Received by Manufacturer: 01/23/2023
• Initial Report FDA Received Date: 01/13/2023
• Supplement Report FDA Received Date: 02/16/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 05/21/2019
• 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