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

Model Number 04.01.0027

Device Problem Appropriate Term/Code Not Available (3191)

Patient Problem Loss of Range of Motion (2032)

Event Date 10/19/2022

Event Type  Injury  

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 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
• Type of Device: 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
• MDR Text Key: 303229285
• Report Number: 3005180920-2022-00842
• Device Sequence Number: 1
• Product Code: KWS
• UDI-Device Identifier: 07630040712651
• UDI-Public: 07630040712651
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K170910
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Company Representative
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 11/08/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/08/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: 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
• Date Manufacturer Received: 10/19/2022
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 12/19/2018
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Sex: Female