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

Model Number	04.01.0024
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Pain (1994)
Date of Event	11/29/2022
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Batch review performed on (b)(6) 2022 : lot 1710035: 70 items manufactured and released on 28-may-2018.Expiration date: 2023-05-13.No anomalies found related to the problem.To date, 44 items of the same lot have been sold without any similar reported event in the period of review.Additional implants involved: batch review performed on (b)(6) 2022 on anatomical shoulder system 04.01.0089 double eccenter (k170910) lot.181485: lot 181485: 198 items manufactured and released on 08-may-2018.Expiration date: 2023-04-26.No anomalies found related to the problem.To date, 176 items of the same lot have been sold without any similar reported event in the period of review.Batch review performed on (b)(6) 2022 on anatomical shoulder system 04.01.0093 metal humeral head ø46 (k170910) lot.167986: lot 167986: 38 items manufactured and released on 04-may-2017.Expiration date: 2022-04-17.No anomalies found related to the problem.To date, 36 items of the same lot have been sold without any similar reported event in the period of review.Batch review performed on (b)(6) 2022 on anatomical shoulder system 04.01.0131 hc pegged glenoid ø46 (k170910) lot.182675: lot 182675: 96 items manufactured and released on 27-sep-2018.Expiration date: 2023-09-17.No anomalies found related to the problem.To date, 89 items of the same lot have been sold without any similar reported event in the period of review.
Event or Problem Description
The patient came in for a post-op appointment and poor range of motion was observed.The surgeon at about 3 years and 4 months post primary decided to remove all components except the stem.The surgery was completed successfully.

• Brand Name: ANATOMICAL SHOULDER SYSTEM HUMERAL ANATOMICAL METAPHYSIS - CEMENTLESS
• Common Device Name: SHOULDER CEMENTLESS 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: 16032690
• Report Number: 3005180920-2022-00947
• Device Sequence Number: 7224236
• Product Code: KWS
• UDI-Device Identifier: 07630040712620
• UDI-Public: 07630040712620
• 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): 12/22/2022

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: 05/13/2023
• Device Model Number: 04.01.0024
• Device Catalogue Number: 04.01.0024
• Device Lot Number: 1710035
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/29/2022
• Initial Report FDA Received Date: 12/22/2022
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 05/28/2018
• 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: Male