MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA ANATOMICAL SHOULDER SYSTEM METAL HUMERAL HEAD 46; SHOULDER HUMERAL HEAD

Model Number	04.01.0093
Health Effect - Clinical Code	Loss of Range of Motion (2032)
Date of Event	09/21/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Batch review performed on 28 september 2021.Lot 1908187: (b)(4) items manufactured and released on 12-feb-2020.Expiration date: 2025-02-02.No anomalies found related to the problem.To date, (b)(4) items of the same lot have been sold without any similar reported event.Additional items related to the event: anatomical shoulder system 04.01.0089 double eccenter lot.2001146.Batch review performed on 28 september 2021.Lot 2001146: (b)(4) items manufactured and released on 07-july-2020.Expiration date: 2025-06-30.No anomalies found related to the problem.To date, (b)(4) items of the same lot have been sold without any similar reported event.Anatomical shoulder system 04.01.0028 humeral anatomical metaphysis - cementless - 135° - 11 lot.1906626.Batch review performed on 28 september 2021.Lot 1906626: (b)(4) items manufactured and released on 15-nov-2019.Expiration date: 2024-11-04.No anomalies found related to the problem.To date, (b)(4) items of the same lot have been sold without any similar reported event.Anatomical shoulder system 04.01.0131 hc pegged glenoid ø46 lot.1907770.Batch review performed on 01 october 2021.Lot 1907770: (b)(4) items manufactured and released on 04-dec-2019.Expiration date: 2024-11-18.No anomalies found related to the problem.To date, (b)(4) items of the same lot have been sold without any similar reported event.
Event or Problem Description
At 6 months after the primary, the patient came in reporting pain and lack of range of motion and the cause is unknown.The surgeon revised the glenoid, head, double eccenter, and proximal body.The surgery was completed successfully.

• Brand Name: ANATOMICAL SHOULDER SYSTEM METAL HUMERAL HEAD 46
• Common Device Name: SHOULDER HUMERAL HEAD
• Manufacturer (Section D): MEDACTA INTERNATIONAL SA; strada regina; castel san pietro, 6874 ; SZ 6874
• MDR Report Key: 12663709
• Report Number: 3005180920-2021-00815
• Device Sequence Number: 4232986
• Product Code: KWS
• UDI-Device Identifier: 07630040713160
• UDI-Public: 07630040713160
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K170910
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2021
• Device Explanted Year: 2021
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: other
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 10/20/2021

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 Expiration Date: 02/02/2025
• Device Model Number: 04.01.0093
• Device Catalogue Number: 04.01.0093
• Device Lot Number: 1908187
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/21/2021
• Initial Report FDA Received Date: 10/20/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention