MAUDE Adverse Event Report: WALDEMAR LINK GMBH & CO. KG LINK BIMOBILE INLAY; BIMOBILE SYSTEM, INLAY, UHMWPE

Model Number 184-250/03

Device Problem Positioning Problem (3009)

Patient Problem Insufficient Information (4580)

Event Date 09/21/2020

Event Type  malfunction  

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 Description

Prosthesis head could not be moved in the inlay of the cup.(translation).

• Brand Name: LINK BIMOBILE INLAY
• Type of Device: BIMOBILE SYSTEM, INLAY, UHMWPE
• Manufacturer (Section D): WALDEMAR LINK GMBH & CO. KG; barkhausenweg 10; hamburg, 22339 ; GM 22339
• Manufacturer (Section G): WALDEMAR LINK GMBH & CO. KG; barkhausenweg 10; hamburg, 22339 ; GM 22339
• Manufacturer Contact: annerike-tizia hucklenbroch ; barkhausenweg 10; hamburg, 22339 ; GM 22339
• MDR Report Key: 10711121
• MDR Text Key: 212306635
• Report Number: 3004371426-2020-00014
• Device Sequence Number: 1
• Product Code: MEH
• Combination Product (y/n): N
• PMA/PMN Number: K171273
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial
• Report Date: 09/22/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/21/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 184-250/03
• Device Catalogue Number: 184-250/03
• Device Lot Number: 2024227
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 09/22/2020
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 08/01/2020
• 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): Other