MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA REVERSE SHOULDER SYSTEM GLENOID BASEPLATE Ø27X35; SHOULDER GLENOID BASEPLATE

Model Number	04.01.0156
Medical Device Problem Code	Osseointegration Problem (3003)
Health Effect - Clinical Codes	Inflammation (1932); Inadequate Osseointegration (2646)
Date of Event	08/04/2022
Type of Reportable Event	Serious Injury
Event or Problem Description
Revision surgery at about 1 year and 4 months after the previous revision surgery, of non medacta components (which was replaced by nickelfree medacta reverse products with femur head bone graft), due glenoid baseplate mobilization and the longest polyaxial screw breakage.All devices have been revised and a cement spacer was implanted successfully.No infection detected till now, the patient shoulder was inflamed.
Additional Manufacturer Narrative
Batch review performed on 09 august 2022: lot 1811891: (b)(4) items manufactured and released on 02-july-2019.Expiration date: 2024-06-17.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 on 19-aug-2022: revision at 1 year and 4 months after the index rsa due to pain and implant mobilization in a 69 year old patient.Previously, the original implant (competitor) was substituted with nickelfree medacta product.According to report, non traumatic inflammation is present while from the radiographic images it is visible the polyaxial screw breakage.It is very likely that the allograft did not integrate causing implant mobilization and therefore the pull out of the glenoid baseplate and screw fracture.During the revision surgery, all devices were revised and cement spacer was implanted successfully.No infection is detected until now.Preliminary investigation performed by r&d project manager on 24-aug-2022: the provided x-rays show mobilization of the glenoid construct likely due to failure of the bone graft and subsequent breakage of the superior screw.The humeral diaphysis and the glenoid baseplate present bone residuals at the bone-implant interface.Additional implanted components: batch review performed on 09 august 2022 on reverse shoulder system 04.01.0164 glenoid polyaxial locking screw - l42 (k170452) lot.2002446: lot 2002446: (b)(4) items manufactured and released on 20-july-2020.Expiration date: 2025-07-12.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.
Additional Manufacturer Narrative
On (b)(6) 2022, the spacer was removed, a hemiprosthesis was implanted, and the glenoid was reconstructed using an iliac crest graft/chip and a spongiosaplasty, with the intention of put back-on a reverse prosthesis when the glenoid had healed.On (b)(6) 2024, after successful glenoid bone reconstruction, the anatomical head, double eccentric, and anatomical metaphysis were removed and a reverse system was implanted.Clinical evaluation performed by medical affairs department revision of a hemiarthroplasty about 1 year and 4 months after it was implanted.The hemiprosthesis was implanted with the removal of a spacer and the glenoid was reconstructed with graft/chip and a spongiosaplasty.The intention was to wait some times before putting on a reverse prosthesis waiting for glenod healing.In fact, this revision consisted in the hemiprosthesis removal and the insertion of the reverse implants.There was no faulty device, the hemiprosthesis was a transition to the final reverse shoulder.

• Brand Name: REVERSE SHOULDER SYSTEM GLENOID BASEPLATE Ø27X35
• Common Device Name: SHOULDER GLENOID BASEPLATE
• Manufacturer (Section D): MEDACTA INTERNATIONAL SA; strada regina; castel san pietro, 6874 ; SZ 6874
• Manufacturer (Section G): MEDACTA INTERNATIONAL SA; strada regina; castel san pietro, 6874 ; SZ 6874
• Manufacturer Contact: stefano baj ; strada regina; castel san pietro, switzerland 6874 ; SZ 6874
• MDR Report Key: 15326887
• Report Number: 3005180920-2022-00661
• Device Sequence Number: 6314624
• Product Code: PHX
• UDI-Device Identifier: 07630040706438
• UDI-Public: 07630040706438
• 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: 2021
• Device Explanted Year: 2022
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 04/10/2024

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: 04.01.0156
• Device Catalogue Number: 04.01.0156
• Device Lot Number: 1811891
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/04/2022
• Supplement Date Received by Manufacturer: 08/04/2022
• Initial Report FDA Received Date: 08/31/2022
• Supplement Report FDA Received Date: 04/10/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• 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: 69 YR
• Patient Sex: Male