MAUDE Adverse Event Report: WALDEMAR LINK GMBH & CO. KG ENDO-MODEL STANDARD KNEE PROSTHESIS SYSTEM

Model Number 15-0027/16

Device Problem Improper or Incorrect Procedure or Method (2017)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 07/05/2023

Event Type  Injury  

Event Description

Linkbio was notified by the representative from earhardt medical that a poly plateau with an expired date of 03/2023 was implanted on (b)(6), 2023.The implant was removed prior to closing and replaced.

• Brand Name: ENDO-MODEL STANDARD KNEE PROSTHESIS SYSTEM
• Type of Device: ENDO-MODEL STANDARD KNEE PROSTHESIS SYSTEM
• Manufacturer (Section D): WALDEMAR LINK GMBH & CO. KG; barkhausenweg 10; hamburg, 22339 ; GM 22339
• MDR Report Key: 17390847
• MDR Text Key: 319758877
• Report Number: 3006721341-2023-00016
• Device Sequence Number: 1
• Product Code: KRO
• UDI-Device Identifier: 04026575432134
• UDI-Public: (01)04026575432134(17)230331(10)1810131
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Distributor
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 07/06/2023,07/25/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/25/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 03/31/2023
• Device Model Number: 15-0027/16
• Device Catalogue Number: 15-0027/16
• Device Lot Number: 1810131
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 07/05/2023
• Event Location: Hospital
• Date Report to Manufacturer: 07/06/2023
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 68 YR
• Patient Sex: Male