MAUDE Adverse Event Report: WALDEMAR LINK GMBH & CO. KG EMBRACE SHOULDER SYSTEM; EMBRACE, REVERSE TRAY, COCRMO NEUTRAL

Model Number 643-242/16

Device Problem Device Dislodged or Dislocated (2923)

Patient Problems Fall (1848); Failure of Implant (1924)

Event Date 05/25/2022

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

Prothesis dislocation.

Event Description

Prothesis dislocation.

Manufacturer Narrative

The review of the device history record showed no deviations.The product complies with the specifications valid at the time of manufacture.

• Brand Name: EMBRACE SHOULDER SYSTEM
• Type of Device: EMBRACE, REVERSE TRAY, COCRMO NEUTRAL
• Manufacturer (Section D): WALDEMAR LINK GMBH & CO. KG; barkhausenweg 10; hamburg, 22339 ; GM 22339
• Manufacturer Contact: lisa effe ; barkhausenweg 10; hamburg, 22339 ; GM 22339
• MDR Report Key: 15120432
• MDR Text Key: 296757914
• Report Number: 3004371426-2022-00026
• Device Sequence Number: 1
• Product Code: PAO
• Combination Product (y/n): N
• Reporter Country Code: IT
• PMA/PMN Number: K200368
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Distributor
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 07/08/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/28/2022
• 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: UNKNOWN
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 07/08/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/01/2020
• 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): Required Intervention
• Patient Age: 37 YR