MAUDE Adverse Event Report: WALDEMAR LINK GMBH & CO. KG ENDO-MODEL SL; CONNECTION COMPONENT

Model Number	16-2840/02
Medical Device Problem Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	Fall (1848)
Date of Event	10/20/2022
Type of Reportable Event	Serious Injury
Event or Problem Description
As notified by (b)(6).To complaints on (b)(6) 2022, surgery on (b)(6) 2022, a revision of sl hinge dfr disassociated out of femur.Through text, information as follows: patient fell and twisted knee badly.No fault of implant.X-ray (attached) shows femur was in a great deal of hyper extension.Waiting information on return of explants.Update (b)(6) 2022: notified by the representative that the explanted parts were discarded by the hospital staff although they were intended to be returned.
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
As notified by (b)(6) to complaints on 10/27/2022, surgery on (b)(6) 2022, a revision of sl hinge dfr disassociated out of femur.Through text, information as follows: patient fell and twisted knee badly.No fault of implant.X-ray shows femur was in a great deal of hyper extension.Waiting information on return of explants.Update on 2022-11-04: notified by the representative that the explanted parts were discarded by the hospital staff although they were intended to be returned.[distributor].

• Brand Name: ENDO-MODEL SL
• Common Device Name: CONNECTION COMPONENT
• 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: 15769860
• Report Number: 3004371426-2022-00045
• Device Sequence Number: 6584263
• 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: 2017
• Device Explanted Year: 2022
• 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): 10/28/2022

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: 04/01/2021
• 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: 10/28/2022
• Supplement Date Received by Manufacturer: 10/28/2022
• Initial Report FDA Received Date: 11/10/2022
• Supplement Report FDA Received Date: 04/11/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 04/01/2016
• 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 Sex: Female