MAUDE Adverse Event Report: WALDEMAR LINK GMBH & CO. KG LINK EMBRACE; EMBRACE, GLENOSPHERE, COCRMO NEUTRAL, Ø 42 MM

Model Number	646-042/00
Medical Device Problem Code	Positioning Failure (1158)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	11/11/2022
Type of Reportable Event	Malfunction
Event or Problem Description
Fixation screw could not be screwed.
Event or Problem Description
Fixation screw could not be screwed.
Additional 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: LINK EMBRACE
• Common Device Name: EMBRACE, GLENOSPHERE, COCRMO NEUTRAL, Ø 42 MM
• 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: 15932018
• Report Number: 3004371426-2022-00047
• Device Sequence Number: 12397996
• Product Code: PAO
• UDI-Device Identifier: 04026575240777
• UDI-Public: 04026575240777
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• PMA/510(K) Number: K200368
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Company Representative
• Initial Reporter Occupation: Biomedical Engineer
• Type of Report: Initial,Followup
• Report Date (Section B): 11/11/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: 646-042/00
• Device Catalogue Number: 646-042/00
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/15/2022
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/11/2022
• Supplement Date Received by Manufacturer: 11/11/2022
• Initial Report FDA Received Date: 12/07/2022
• Supplement Report FDA Received Date: 04/17/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/01/2022
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 59 YR
• Patient Sex: Male