MAUDE Adverse Event Report: WALDEMAR LINK GMBH & CO. KG ENDO-MODEL ROTATIONAL KNEE PROSTHESIS; TIBIAL PLATEAU, NEUTRAL LARGE, UHMWPE, COCRMO, WITH ANTI-LUXATION DEVICE, V02

Model Number	15-0027/10
Medical Device Problem Code	Expiration Date Error (2528)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	07/05/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
Distributor was notified by sales rep 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.[customer].
Additional Manufacturer Narrative
The review of the device history record showed no deviations.The product and all labels comply with the specifications valid at the time of manufacture.
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
Distributor was notified by sales rep 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.[customer].

• Brand Name: ENDO-MODEL ROTATIONAL KNEE PROSTHESIS
• Common Device Name: TIBIAL PLATEAU, NEUTRAL LARGE, UHMWPE, COCRMO, WITH ANTI-LUXATION DEVICE, V02
• Manufacturer (Section D): WALDEMAR LINK GMBH & CO. KG; barkhausenweg 10; hamburg, 22339 ; GM 22339
• Manufacturer Contact: tizia hucklenbroch ; barkhausenweg 10; hamburg, 22339 ; GM 22339
• MDR Report Key: 17457771
• Report Number: 3004371426-2023-00070
• Device Sequence Number: 2698234
• Product Code: KRO
• UDI-Device Identifier: 04026575432134
• UDI-Public: 04026575432134
• Combination Product (Y/N): N
• Initial Reporter State: NJ
• Initial Reporter Country: US
• PMA/510(K) Number: K143179
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2023
• Device Explanted Year: 2023
• 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): 07/06/2023

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: 03/01/2023
• Device Model Number: 15-0027/10
• Device Catalogue Number: 15-0027/10
• Device Lot Number: 1810131
• 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: 07/06/2023
• Supplement Date Received by Manufacturer: 07/06/2023
• Initial Report FDA Received Date: 08/04/2023
• Supplement Report FDA Received Date: 08/18/2023
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 03/01/2018
• 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: Other
• Patient Sex: Unknown