MAUDE Adverse Event Report: WALDEMAR LINK GMBH & CO. KG NECK SEGMENT XXL WITHOUT COLLAR MP RECONSTRUCTION PROSTHESIS, CEMENTLESS; PRESS-FIT HIP FEMUR PROSTHESIS, MODULAR

Model Number 99-0984/28

Device Problem Detachment of Device or Device Component (2907)

Patient Problem Bone Fracture(s) (1870)

Event Date 05/25/2017

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 period, when the item was produced.The problem occured due to the combination of components which are not compatible.The surgical technique gives sufficient and detailed information about how to combine the different components.The visual investigation of the complaint samples confirms that all samples maintain their specifications.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

It was reported that at the moment of impacting the head the neck showed loosening.While proceeding to remove the fixation of the system the distal femur fractured.

• Brand Name: NECK SEGMENT XXL WITHOUT COLLAR MP RECONSTRUCTION PROSTHESIS, CEMENTLESS
• Type of Device: PRESS-FIT HIP FEMUR PROSTHESIS, MODULAR
• 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: 8296393
• MDR Text Key: 134708362
• Report Number: 3004371426-2019-00068
• Device Sequence Number: 1
• Product Code: LZO
• Combination Product (y/n): N
• Reporter Country Code: CO
• PMA/PMN Number: K142187
• 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: 06/12/2017

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: 04/30/2022
• Device Model Number: 99-0984/28
• Device Catalogue Number: 99-0984/28
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/23/2017
• Date Manufacturer Received: 06/12/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/01/2017
• 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