MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA SHOULDER SYSTEM; SHOULDER GLENOID POLYAXIAL LOCKING SCREW

Model Number	04.01.0159
Medical Device Problem Codes	Fracture (1260); Device Appears to Trigger Rejection (1524)
Health Effect - Clinical Codes	Metal Related Pathology (4530); Medical device site infection (4845)
Date of Event	12/04/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
Revision surgery performed 1 year and 9 months after the primary surgery due to suspected septic loosening and metallosis on the humeral and glenoid part.Bone graft used in primary surgery.One polyaxial screw was found broken.All implants were removed and a spacer was put in.
Additional Manufacturer Narrative
Batch review performed on 12-dec-2024: lot 2240567: (b)(4) items manufactured and released on 12-dec-2022.Expiration date: 2027-11-22.No anomalies found related to the problem.To date, all items of the same lot have been sold, no similar reported event during the period of review.Clinical evaluation performed by medical affairs department: revision surgery performed 1 year and 9 months after the primary rsa due to suspected septic loosening and metallosis on the humeral and glenoid part.If the loosening is septic, the infection is a known possible adverse event following every surgery, including tha's.While, we do not have enough information to determine the origin of the metallosis.Preliminary investigation performed by r&d project manager: the provided pictures confirm the breakage of one polyaxial screw and the presence of metallosis on the baseplate.Given the information at hand it is not possible to determine the root cause of the event.Additional implants involved: batch review performed on 12-dec-2024 on reverse shoulder system 04.01.0284 humeral eccentric reverse metaphysis +0mm/+3mm (k210207) lot.2239189: lot 2239189: (b)(4) items manufactured and released on 02-feb-2023.Expiration date: 2028-01-19.No anomalies found related to the problem.To date, (b)(4) items of the same lot have been sold, no similar reported event during the period of review.Batch review performed on 12-dec-2024 on reverse shoulder system 04.01.0122 humeral reverse hc liner ø39/+0mm (k170452) lot.2240222: lot 2240222: (b)(4) items manufactured and released on 03-jan-2023.Expiration date: 2027-12-01.No anomalies found related to the problem.To date, all items of the same lot have been sold, no similar reported event during the period of review.Batch review performed on 12-dec-2024 on reverse shoulder system 04.01.0173 glenosphere - ø39x27 (k170452) lot.2240241: lot 2240241: (b)(4) items manufactured and released on 05-dec-2022.Expiration date: 2027-11-21.No anomalies found related to the problem.To date, (b)(4) items of the same lot have been sold, no similar reported event during the period of review.Batch review performed on 12-dec-2024 on reverse shoulder system 04.01.0164 glenoid polyaxial locking screw - l42 (k170452) lot.2211008: lot 2211008: (b)(4) items manufactured and released on 28-jun-2022.Expiration date: 2027-06-09.No anomalies found related to the problem.To date, (b)(4) items of the same lot have been sold, no similar reported event during the period of review.Batch review performed on 12-dec-2024 on reverse shoulder system 04.01.0155 glenoid baseplate - ø27x25 (k170452) lot.2242351: lot 2242351: (b)(4) items manufactured and released on 28-feb-2023.Expiration date: 2028-02-13.No anomalies found related to the problem.To date, all items of the same lot have been sold, no similar reported event during the period of review.Batch review performed on 12-dec-2024 on reverse shoulder system 04.01.0165 glenoid polyaxial locking screw - l46 (k170452) lot.2117100: lot 2117100: (b)(4) items manufactured and released on 20-jan-2022.Expiration date: 2027-01-10.No anomalies found related to the problem.To date, (b)(4) items of the same lot have been sold, no similar reported event during the period of review.Batch review performed on 12-dec-2024 on reverse shoulder system 04.01.0182 short humeral diaphysis - cementless - 9 (k180089) lot.2243577: lot 2243577: (b)(4) items manufactured and released on 19-jan-2023.Expiration date: 2028-01-03.No anomalies found related to the problem.To date, (b)(4) items of the same lot have been sold, no similar reported event during the period of review.Batch review performed on 12-dec-2024 on reverse shoulder system 04.01.0201 glenoid polyaxial non-locking screw - l42 (k181826) lot.2246466: lot 2246466: (b)(4) items manufactured and released on 01-feb-2023.Expiration date: 2028-01-12.No anomalies found related to the problem.To date, (b)(4) items of the same lot have been sold, no similar reported event during the period of review.

• Brand Name: SHOULDER SYSTEM
• Common Device Name: SHOULDER GLENOID POLYAXIAL LOCKING SCREW
• 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: marco giannessi ; strada regina; castel san pietro, switzerland 6874 ; SZ 6874
• MDR Report Key: 21026680
• Report Number: 3005180920-2024-01114
• Device Sequence Number: 13017454
• Product Code: PHX
• UDI-Device Identifier: 07630040706469
• UDI-Public: 07630040706469
• 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: 2023
• Device Explanted Year: 2024
• 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): 12/27/2024

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: 04.01.0159
• Device Lot Number: 2240567
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/04/2024
• Initial Report FDA Received Date: 12/27/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 12/12/2022
• 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: 63 YR
• Patient Sex: Male