MAUDE Adverse Event Report: WALDEMAR LINK GMBH & CO. KG LINK SLED PROSTHESIS; PLATEAU

Model Number	15-2028/13
Medical Device Problem Code	Crack (1135)
Health Effect - Clinical Code	Failure of Implant (1924)
Date of Event	06/13/2022
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
Crack of polyethylene plateau.

• Brand Name: LINK SLED PROSTHESIS
• Common Device Name: PLATEAU
• 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: 14875413
• Report Number: 3004371426-2022-00025
• Device Sequence Number: 5073805
• Product Code: KRO
• UDI-Device Identifier: 04026575359455
• UDI-Public: 04026575359455
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• PMA/510(K) Number: K152431
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2021
• Device Explanted Year: 2022
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Foreign
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 06/17/2022

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: 09/30/2021
• Device Model Number: 15-2028/13
• Device Catalogue Number: 15-2028/13
• Device Lot Number: 1633016
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/29/2022
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/17/2022
• Initial Report FDA Received Date: 06/30/2022
• Date Device Manufactured: 09/01/2021
• 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: 78 YR
• Patient Sex: Male
• Patient Weight: 120 KG