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

Model Number	04.01.0093
Health Effect - Clinical Codes	Failure of Implant (1924); Pain (1994)
Date of Event	06/01/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Batch review performed on 11 june 2021: lot 189736: (b)(4) items manufactured and released on 28-mar-2019.Expiration date: 2024-mar-18.No anomalies found related to the problem.To date, (b)(4) items of the same lot have been already sold.No other similar event has been reported for this lot.Additional devices involved: batch reviews performed on 11 june 2021: anatomical shoulder system 04.01.0089 double eccenter (k170910) lot 1902185: (b)(4) items manufactured and released on 28-jun-2019.Expiration date: 2024-jun-16.No anomalies found related to the problem.To date, (b)(4) items of the same lot have been already sold.No other similar event has been reported for this lot.Anatomical shoulder system 04.01.0026 humeral anatomical metaphysis - cementless - 135° - 9 (k170910) lot 1906624: (b)(4) items manufactured and released on 15-nov-2019.Expiration date: 2024-nov-04.No anomalies found related to the problem.To date, (b)(4) items of the same lot have been already sold.No other similar event has been reported for this lot.Anatomical shoulder system 04.01.0133 hc pegged glenoid ø50 (k170910) lot 184441: (b)(4) items manufactured and released on 4-feb-2019.Expiration date: 2024-gen-24.No anomalies found related to the problem.To date, (b)(4) items of the same lot have been already sold.No other similar event has been reported for this lot.
Event or Problem Description
1 year and 5 months after the primary surgery the patient came in reporting pain due to a failed subscapularis and the cause is unknown.The surgeon revised the humeral head, humeral anatomic metaphysis, double eccenter, and hc pegged glenoid.The surgery was completed successfully.

• Brand Name: ANATOMICAL SHOULDER SYSTEM METAL HUMERAL HEAD 46
• Common Device Name: SHOULDER METALLIC HEAD
• Manufacturer (Section D): MEDACTA INTERNATIONAL SA; strada regina; castel san pietro, 6874 ; SZ 6874
• MDR Report Key: 12098250
• Report Number: 3005180920-2021-00528
• Device Sequence Number: 4259819
• 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: 2020
• Device Explanted Year: 2021
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: other
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 07/01/2021

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: 03/18/2024
• Device Model Number: 04.01.0093
• Device Catalogue Number: 04.01.0093
• Device Lot Number: 189736
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/01/2021
• Initial Report FDA Received Date: 07/01/2021
• 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