MAUDE Adverse Event Report: WALDEMAR LINK GMBH & CO. KG VARIO-CUP PROSTHESIS - SELF-CENTERING WITH SAFETY RING - CEMENTLESS; FEMORAL HEAD BIPOLAR COMPONENT

Model Number 107-220/48

Device Problem Detachment of Device or Device Component (2907)

Patient Problem Failure of Implant (1924)

Event Date 12/08/2015

Event Type  Injury  

Manufacturer Narrative

The review of the device history record showed no deviations.All product features correspond with the valid specifications of the waldemar link (b)(4) at the time, when the item was produced.According to the reporting person there is no chance of getting the complaint sample and any further information like x-rays, incident description, patient details or anything else.Without the requested information a detailed investigation is not possible.According to the quality documentation review and the investigation results we exclude a product failure.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 after 40 days the vario-cup dislocated form acetabulum.

• Brand Name: VARIO-CUP PROSTHESIS - SELF-CENTERING WITH SAFETY RING - CEMENTLESS
• Type of Device: FEMORAL HEAD BIPOLAR COMPONENT
• 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: 8296316
• MDR Text Key: 134710101
• Report Number: 3004371426-2019-00029
• Device Sequence Number: 1
• Product Code: KWY
• Combination Product (y/n): N
• Reporter Country Code: IT
• PMA/PMN Number: 781735
• 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: 12/21/2015

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: 10/31/2019
• Device Model Number: 107-220/48
• Device Catalogue Number: 107-220/48
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 12/21/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 10/01/2014
• 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: 75 YR
• Patient Weight: 70