MAUDE Adverse Event Report: WALDEMAR LINK GMBH & CO. KG LINK® ENDO-MODEL® SLED PROSTHESIS

Model Number	15-2220/52
Medical Device Problem Code	Patient Device Interaction Problem (4001)
Health Effect - Clinical Code	Failure of Implant (1924)
Date of Event	09/13/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
After reevaluation of the event information we determined the event is reportable.
Event or Problem Description
It was reported a aseptic loosening.
Additional Manufacturer Narrative
The review of the device history record showed no deviations.All product features corresponded with the valid specifications of the waldemar link gmbh & co.Kg at the time period, when the item was produced.
Event or Problem Description
It was reported a aseptic loosening.

• Brand Name: LINK® ENDO-MODEL® SLED PROSTHESIS
• Common Device Name: LINK® ENDO-MODEL® SLED PROSTHESIS
• Manufacturer (Section D): WALDEMAR LINK GMBH & CO. KG; barkhausenweg 10; hamburg, 22339 ; GM 22339
• MDR Report Key: 8212099
• Report Number: 3004371426-2019-00001
• Device Sequence Number: 2025236
• Product Code: KRO
• UDI-Device Identifier: 04026575429097
• UDI-Public: 04026575429097
• Combination Product (Y/N): N
• Initial Reporter Country: IT
• PMA/510(K) Number: K152431
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2018
• Device Explanted Year: 2018
• Reporter Type: Manufacturer
• Report Source: foreign
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 10/04/2018

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: 01/01/2018
• Device Model Number: 15-2220/52
• Device Catalogue Number: 15-2220/52
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/09/2019
• Initial Date Received by Manufacturer: 10/04/2018
• Supplement Date Received by Manufacturer: 10/04/2018
• Initial Report FDA Received Date: 01/03/2019
• Supplement Report FDA Received Date: 01/17/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 63 YR