MAUDE Adverse Event Report: WALDEMAR LINK GMBH & CO. KG CUSTOM MADE DEVICE; ROTATIONAL KNEE PROSTH. ENDO-MODEL-M, INTRACONDYLAR, LEFT, LARGE, ZRN COATING

Model Number 313-03381

Device Problem Loosening of Implant Not Related to Bone-Ingrowth (4002)

Patient Problems Bone Fracture(s) (1870); Hypersensitivity/Allergic reaction (1907)

Event Date 12/29/2022

Event Type  Injury  

Event Description

The revision was due to cement loosening and the cement loosening was: for the femur at both the cement/device and cement/bone interfaces, and for the tibia at the cement/bone interface only.Dr.(b)(6) also mentions observing at the revision a thick white material in the knee of unknown nature that he believes is not typical of ti loosening and may have been related to the coating.

Manufacturer Narrative

The review of the device history records showed no deviations.All product features and sterilization documents corresponded with the valid specifications of the waldemar link gmbh & co.Kg at the time period, when the item was produced.

Event Description

The revision was due to cement loosening and the cement loosening was: for the femur at both the cement/device and cement/bone interfaces, and for the tibia at the cement/bone interface only.Dr.(b)(6) also mentions observing at the revision a thick white material in the knee of unknown nature that he believes is not typical of ti loosening and may have been related to the coating.[distributor].

Manufacturer Narrative

The review of the device history record showed no deviations.The product complies with the specifications valid at the time of manufacture.

• Brand Name: CUSTOM MADE DEVICE
• Type of Device: ROTATIONAL KNEE PROSTH. ENDO-MODEL-M, INTRACONDYLAR, LEFT, LARGE, ZRN COATING
• 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: 17132860
• MDR Text Key: 317206833
• Report Number: 3004371426-2023-00050
• Device Sequence Number: 1
• Product Code: KRO
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Distributor
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 05/24/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/15/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 313-03381
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 05/24/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 12/01/2020
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 59 YR
• Patient Sex: Male
• Patient Weight: 91 KG