MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA ANATOMICAL SHOULDER SYSTEM HUMERAL ANATOMICAL METAPHYSIS - CEMENTLESS; SHOULDER ANATOMICAL METAPHYSIS

Model Number	04.01.0027
Medical Device Problem Code	Appropriate Device Problem Term/Code Not Available (3191)
Health Effect - Clinical Code	Loss of Range of Motion (2032)
Date of Event	10/19/2022
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Batch review performed on 28-oct-2022: lot 184527: (b)(4) items manufactured and released on 19-dec-2018.Expiration date: 2023-12-11.No anomalies found related to the problem.To date, (b)(4) items of the same lot have been sold with another similar reported case during the period of the review.Additional info request.Batch review performed on 28-oct-2022: anatomical shoulder system 04.01.0130 hc pegged glenoid ø44 (k170910) lot 181488: (b)(4) items manufactured and released on 13-jun-2018.Expiration date: 2023-06-03.No anomalies found related to the problem.To date, (b)(4) items of the same lot have been sold with no similar reported case during the period of the review.Anatomical shoulder system 04.01.0092 metal humeral head ø44 (k170910) lot 1710136: (b)(4) items manufactured and released on 24-may-2018.Expiration date: 2023-05-14.No anomalies found related to the problem.To date, (b)(4) items of the same lot have been sold with another similar reported case during the period of the review.Clinical evaluation performed by medacta medical affairs director: revision 3 years and 4 months after primary due to pain and difficulty with rom and, according to report, the cause is unknown.The surgeon revised the patient from anatomic to reverse and the surgery was completed successfully.The only radiographic image provided and the generic report do not release useful information.Therefore, no final conclusions can be given with the information at hand.
Event or Problem Description
The patient came in reporting pain and difficulty with rom and the cause is unknown.At about 3 years and 4 months from primary the surgeon revised the patient from anatomic to reverse and the surgery was completed successfully.

• Brand Name: ANATOMICAL SHOULDER SYSTEM HUMERAL ANATOMICAL METAPHYSIS - CEMENTLESS
• Common Device Name: SHOULDER ANATOMICAL METAPHYSIS
• 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: 15751575
• Report Number: 3005180920-2022-00842
• Device Sequence Number: 12341595
• Product Code: KWS
• UDI-Device Identifier: 07630040712651
• UDI-Public: 07630040712651
• Combination Product (Y/N): N
• Initial Reporter State: IL
• Initial Reporter Country: US
• PMA/510(K) Number: K170910
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2019
• Device Explanted 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): 11/08/2022

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?: No
• Operator of Device: Health Professional
• Device Expiration Date: 12/11/2023
• Device Model Number: 04.01.0027
• Device Catalogue Number: 04.01.0027
• Device Lot Number: 184527
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/19/2022
• Initial Report FDA Received Date: 11/08/2022
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 12/19/2018
• 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 Sex: Female