MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA ANATOMICAL SHOULDER SYSTEM METAL HUMERAL HEAD Ø44; SHOULDER METAL HUMERAL HEAD

Model Number	04.01.0092
Medical Device Problem Code	Device Dislodged or Dislocated (2923)
Health Effect - Clinical Code	Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available (4581)
Type of Reportable Event	Serious Injury
Event or Problem Description
The patient presents a glenohumeral dislocation on her anatomical prosthesis.On (b)(6) 2023 revision planned to change to reverse system.
Additional Manufacturer Narrative
The surgeon will change the prosthesis on (b)(6) 2023 into reverse.The information will be updated when available after the revision surgery.Additional implant to be probably revised: anatomical shoulder system 04.01.0130 hc pegged glenoid ø44 lot.Unknown.

• Brand Name: ANATOMICAL SHOULDER SYSTEM METAL HUMERAL HEAD Ø44
• Common Device Name: SHOULDER METAL HUMERAL HEAD
• Manufacturer (Section D): MEDACTA INTERNATIONAL SA; strada regina; castel san pietro, switzerland 6874 ; SZ 6874
• Manufacturer (Section G): MEDACTA INTERNATIONAL SA; strada regina; castel san pietro, switzerland 6874 ; SZ 6874
• Manufacturer Contact: stefano baj ; strada regina; castel san pietro, switzerland 6874 ; SZ 6874
• MDR Report Key: 16563758
• Report Number: 3005180920-2023-00172
• Device Sequence Number: 14843043
• Product Code: KWS
• UDI-Device Identifier: 07630040713153
• UDI-Public: 07630040713153
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• PMA/510(K) Number: K170910
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2022
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 03/17/2023

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?: No
• Operator of Device: Health Professional
• Device Model Number: 04.01.0092
• Device Catalogue Number: 04.01.0092
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/17/2023
• Initial Report FDA Received Date: 03/17/2023
• Was Device Evaluated by Manufacturer? (Y/N): No
• 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: 74 YR
• Patient Sex: Female
• Patient Weight: 59 KG