MAUDE Adverse Event Report: WALDEMAR LINK GMBH & CO. KG FEMORAL COMPONENT INTRACONDYLAR - MODULAR - CEMENTED ROTATIONAL KNEE SL; UNCOATED KNEE FEMUR PROSTHESIS

Model Number 16-2825/21

Device Problems Crack (1135); Detachment of Device or Device Component (2907); Loosening of Implant Not Related to Bone-Ingrowth (4002)

Patient Problem Failure of Implant (1924)

Event Date 09/25/2017

Event Type  Injury  

Manufacturer Narrative

The review of the device history record showed no deviations.All product features corresponded with the valid specifications of the waldemar link (b)(4) at the time, when the item was produced.The reported event is confirmed through investigation.Based on the investigations there is no indication to suggest a material or manufacturing defect.The report is delayed due to inconsistencies with regard to foreign event reporting to fda.After re-evaluation of the complaint we determined that it is reportable.We have addressed the inconsistency in reporting foreign events to fda through capa (b)(4).

Event Description

A detachment of the femoral component from the stem was reported.

• Brand Name: FEMORAL COMPONENT INTRACONDYLAR - MODULAR - CEMENTED ROTATIONAL KNEE SL
• Type of Device: UNCOATED KNEE FEMUR PROSTHESIS
• Manufacturer (Section D): WALDEMAR LINK GMBH & CO. KG; barkhausenweg 10; hamburg, 22339 ; GM 22339
• Manufacturer Contact: rebekka winterhoff ; barkhausenweg 10; hamburg, 22339 ; GM 22339
• MDR Report Key: 8296398
• MDR Text Key: 134708579
• Report Number: 3004371426-2019-00087
• Device Sequence Number: 1
• Product Code: KRO
• Combination Product (y/n): N
• Reporter Country Code: GM
• PMA/PMN Number: K151008
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 09/25/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/01/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 07/31/2019
• Device Model Number: 16-2825/21
• Device Catalogue Number: 16-2825/21
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/11/2018
• Date Manufacturer Received: 09/25/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/01/2014
• 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: 60 YR
• Patient Weight: 130