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

Model Number	16-2840/05
Medical Device Problem Codes	Degraded (1153); Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	Failure of Implant (1924)
Date of Event	03/01/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
Notified on 3/6/2024 by representative (b)(6), that on (b)(6) 2024, dr.(b)(6) performed a revision surgery for an endo sl that had a disassociated connection component.At review of pre-op x-rays it was still unclear as to the issue.When opened, it was clear that the components were disassociated.The representative stated that the connection components pieces were "exploded" within the patient, that they were spread out within the joint.All the pieces were removed and this extended the surgery approximately 30 minutes.The patient was revised to an endo w.[customer].
Event or Problem Description
Notified on 3/6/2024 by representative (b)(4), that on (b)(6) 2024, dr.(b)(6) performed a revision surgery for an endo sl that had a disassociated connection component.At review of pre-op x-rays it was still unclear as to the issue.When opened, it was clear that the components were disassociated.The representative stated that the connection components pieces were "exploded" within the patient, that they were spread out within the joint.All the pieces were removed and this extended the surgery approximately 30 minutes.The patient was revised to an endo w.[customer].
Additional Manufacturer Narrative
This is the final supplemental report, the complaint is closed.

• Brand Name: ENDO-MODEL SL KNEE JOINT PROSTHESIS
• Common Device Name: CONNECTION COMPONENTROTATIONAL VERSION,MEDIUM
• Manufacturer (Section D): WALDEMAR LINK GMBH & CO.KG; barkhausenweg 10; hamburg, 22339 ; GM 22339
• Manufacturer Contact: annerike tizia hucklenbroch ; barkhausenweg 10; hamburg, 22339 ; GM 22339
• MDR Report Key: 19031241
• Report Number: 3004371426-2024-00024
• Device Sequence Number: 18172853
• Product Code: KRO
• UDI-Device Identifier: 04026575359240
• UDI-Public: 04026575359240
• 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: 2017
• Device Explanted Year: 2024
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Distributor
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 03/06/2024

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
• Operator of Device: Health Professional
• Device Expiration Date: 08/01/2021
• Device Model Number: 16-2840/05
• Device Catalogue Number: 16-2840/05
• 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: 03/06/2024
• Supplement Date Received by Manufacturer: 03/06/2024
• Initial Report FDA Received Date: 04/03/2024
• Supplement Report FDA Received Date: 07/16/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/01/2016
• 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: 76 YR
• Patient Sex: Male