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

Model Number NR124M

Device Problems Device Dislodged or Dislocated (2923); Manufacturing, Packaging or Shipping Problem (2975)

Patient Problems Failure of Implant (1924); Joint Dislocation (2374)

Event Date 12/19/2022

Event Type  Injury  

Event 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).

Manufacturer Narrative

Manufacturing site evaluation: investigation on-going.Should relevant additional information / investigation results become available, a supplemental medwatch report will be submitted.

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
• Type of Device: 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
• MDR Text Key: 307321958
• Report Number: 9610612-2022-00384
• Device Sequence Number: 1
• Product Code: JWH
• UDI-Device Identifier: 04046964009464
• UDI-Public: 4046964009464
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K122985
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative
• Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date: 02/16/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/13/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• 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
• Date Manufacturer Received: 01/23/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 05/21/2019
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention