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	Fracture (1260); Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	Failure of Implant (1924)
Date of Event	12/19/2023
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The review of the device history record showed no deviations.The product complies with the specifications valid at the time of manufacture.
Event or Problem Description
Notified on 12/19/23 by (b)(6) regarding a revision case with dr.(b)(6) on (b)(6) 2023 for what was thought to be a failed connection component.At surgery, it was found that the connection component was intact but the plastic bearings were broken in the femur.The revision replaced the connection component and bearings and the outcome was successful.Initial surgery date was (b)(6) 2022 with same surgeon.Explanted devices have been discarded.[customer].
Additional Manufacturer Narrative
This is the final supplemental report.The complaint is closed.
Event or Problem Description
Notified on (b)(6) 2023 by (b)(6) regarding a revision case with dr.(b)(6) on (b)(6) 2023 for what was thought to be a failed connection component.At surgery, it was found that the connection component was intact but the plastic bearings were broken in the femur.The revision replaced the connection component and bearings and the outcome was successful.Initial surgery date was on (b)(6) 2022 with same surgeon.Explanted devices have been discarded.[customer].

• 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: 18542327
• Report Number: 3004371426-2024-00007
• Device Sequence Number: 12743456
• 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: 2023
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Distributor
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 12/20/2023

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 Model Number: 16-2840/02
• Device Catalogue Number: 16-2840/02
• 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: 12/20/2023
• Supplement Date Received by Manufacturer: 12/20/2023
• Initial Report FDA Received Date: 01/19/2024
• Supplement Report FDA Received Date: 08/15/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• 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