MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA REVERSE SHOULDER SYSTEM GLENOID BASEPLATE Ø27X25; SHOULDER GLENOID BASEPLATE

Model Number	04.01.0155
Medical Device Problem Code	Osseointegration Problem (3003)
Health Effect - Clinical Code	Inadequate Osseointegration (2646)
Date of Event	10/26/2022
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Batch review performed on 11-nov-2022.Lot 2110379: (b)(4) items manufactured and released on 22-nov-2021.Expiration date: 2026-11-07.No anomalies found related to the problem.To date, (b)(4) items of the same lot have been sold without any similar reported event during the period of review.Clinical evaluation performed by medical affairs department.Revision 7 months after the primary surgery in a 89 year old female patient due to mobilization of the baseplate that caused the joint luxation.According to the report, there was no fall or infection.In the primary surgery, an autograft was used.It may be possible that there was no integration and therefore the mobilization of the graft and the baseplate.According to the report, the autograft was of poor quality as the bone of the patient where it came from.This problem is not related to a faulty implant.
Event or Problem Description
Revision surgery performed due to mobilization of the baseplate with autograft that caused the joint luxation, 7 months after the primary surgery.The patient has poor bone quality.The autograft was not of good quality.All implants, except for the humeral short stem, were revised.

• Brand Name: REVERSE SHOULDER SYSTEM GLENOID BASEPLATE Ø27X25
• Common Device Name: SHOULDER GLENOID BASEPLATE
• 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: 15796635
• Report Number: 3005180920-2022-00861
• Device Sequence Number: 17279612
• Product Code: PHX
• UDI-Device Identifier: 07630040706421
• UDI-Public: 07630040706421
• Combination Product (Y/N): N
• Initial Reporter Country: SZ
• PMA/510(K) Number: K170452
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2022
• 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): 11/15/2022

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 Model Number: 04.01.0155
• Device Catalogue Number: 04.01.0155
• Device Lot Number: 2110379
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/26/2022
• Initial Report FDA Received Date: 11/15/2022
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 11/22/2021
• 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 Age: 89 YR
• Patient Sex: Female
• Patient Weight: 47 KG