MAUDE Adverse Event Report: WALDEMAR LINK GMBH & CO. KG ENDO-MODEL SL; CONNECTION COMPONENTROTATIONAL VERSION,SMALL

Model Number	16-2840/02
Medical Device Problem Codes	Detachment of Device or Device Component (2907); Loosening of Implant Not Related to Bone-Ingrowth (4002)
Health Effect - Clinical Code	Failure of Implant (1924)
Date of Event	11/25/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
As reported by representative t.A on (b)(6) 2023 , a patient presented to the emergency room on wednesday on (b)(6) 2023 and found to have a dislocated endo sl component.Revision surgery took place on (b)(6) 2023 and was very successful.Representative stated that the explanted bushings were "destroyed".
Event or Problem Description
As reported by representative (b)(6) on 2023-11-27, a patient presented to the emergency room on wednesday on (b)(6) 2023 and found to have a dislocated endo sl component.Revision surgery took place on (b)(6) 2023 and was very successful.Representative stated that the explanted bushings were "destroyed".[customer].
Additional Manufacturer Narrative
This is the final supplemental report, the complaint is closed.

• Brand Name: ENDO-MODEL SL
• Common Device Name: CONNECTION COMPONENTROTATIONAL VERSION,SMALL
• Manufacturer (Section D): WALDEMAR LINK GMBH & CO. KG; barkhausenweg 10; hamburg, hamburg 22339 ; GM 22339
• Manufacturer Contact: andreas brandt ; barkhausenweg 10; hamburg, hamburg 22339 ; GM 22339
• MDR Report Key: 18309046
• Report Number: 3004371426-2023-00109
• Device Sequence Number: 12416034
• Product Code: KRO
• UDI-Device Identifier: 04026575359233
• UDI-Public: 04026575359233
• Combination Product (Y/N): N
• Initial Reporter State: NJ
• Initial Reporter Country: US
• PMA/510(K) Number: K151008
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2022
• Device Explanted Year: 2024
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,Distributor
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 11/27/2023

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?: No
• Device Expiration Date: 02/28/2022
• Device Model Number: 16-2840/02
• Device Catalogue Number: 16-2840/02
• Device Lot Number: 2038120
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/27/2023
• Supplement Date Received by Manufacturer: 11/27/2023
• Initial Report FDA Received Date: 12/12/2023
• Supplement Report FDA Received Date: 10/29/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 08/01/2021
• 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 Age: 66 YR
• Patient Sex: Female