MAUDE Adverse Event Report: WALDEMAR LINK GMBH & CO. KG VARIO-CUP; VARIO-CUP,43MM O.D.,F. HEAD DIA. 24 MM, WITHOUT SAFETY RING,SELF-CENTERING

Model Number 107-210/43

Device Problem Positioning Failure (1158)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 08/05/2020

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.The report is delayed due to original classification of the case as non-reportable.Due to the recent fda inspection we re-evaluated the complaint in comparison to similar complaints with different outcomes and therefore determined that it is reportable.We have addressed this observation in capa-23-08.

Event Description

Ball heads dislocated from vario-cup-43 mm without safety ring during the operation (not reset).The surgeon finished operation after changing to vario-cup 41 mm.[customer].

• Brand Name: VARIO-CUP
• Type of Device: VARIO-CUP,43MM O.D.,F. HEAD DIA. 24 MM, WITHOUT SAFETY RING,SELF-CENTERING
• Manufacturer (Section D): 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: 17642775
• MDR Text Key: 322199899
• Report Number: 3004371426-2023-00090
• Device Sequence Number: 1
• Product Code: KWY
• UDI-Device Identifier: 04026575329748
• UDI-Public: 04026575329748
• Combination Product (y/n): N
• Reporter Country Code: CH
• PMA/PMN Number: K781735
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 08/11/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/29/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 107-210/43
• Device Catalogue Number: 107-210/43
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 08/11/2020
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 04/01/2020
• 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 Age: 85 YR
• Patient Sex: Female
• Patient Weight: 55 KG