MAUDE Adverse Event Report: WALDEMAR LINK GMBH & CO. KG LINK EMBRACE; REVERSE INSERT

Model Number 643-242/16

Device Problem Device Dislodged or Dislocated (2923)

Patient Problems Failure of Implant (1924); Metal Related Pathology (4530)

Event Date 08/02/2021

Event Type  Injury  

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

Dislocation of insert.

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

Dislocation of insert.

• Brand Name: LINK EMBRACE
• Type of Device: REVERSE INSERT
• Manufacturer (Section D): WALDEMAR LINK GMBH & CO. KG; barkhausenweg 10; hamburg, 22339 ; GM 22339
• MDR Report Key: 12340908
• MDR Text Key: 267212074
• Report Number: 3004371426-2021-00025
• Device Sequence Number: 1
• Product Code: PAO
• Combination Product (y/n): N
• PMA/PMN Number: K200368
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional
• Type of Report: Initial,Followup
• Report Date: 08/09/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/19/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 643-242/16
• Device Catalogue Number: 643-242/16
• Device Lot Number: 2018178
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/13/2021
• Date Manufacturer Received: 08/09/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 66 YR
• Patient Weight: 98