MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA REVERSE SHOULDER SYSTEM SHORT HUMERAL DIAPHYSIS - CEMENTLESS - 10; SHOULDER DIAPHYSIS

Catalog Number	04.01.0183
Medical Device Problem Code	Device Appears to Trigger Rejection (1524)
Health Effect - Clinical Code	Medical device site infection (4845)
Date of Event	07/12/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
At about 1 year and 2 months after the primary, the patient came in reporting pain and resulted positive for curtibacterium acnes.The surgeon performed an analgesic treatment and removed all the implants.The patient is under monitoring.
Additional Manufacturer Narrative
Batch review performed on 26-jul-2023: lot 2110753: (b)(4) items manufactured and released on 02-sep-2021.Expiration date: 2026-08-19.No anomalies found related to the problem.To date, all items of the same lot have been sold with no similar reported case during the period of review.Additional components involved in the event: batch review performed on 26-jul-2023: reverse shoulder system 04.01.0110 humeral reverse metaphysis +0mm/0° (k1704529) lot 2108989: (b)(4) items manufactured and released on 16-feb-2022.Expiration date: 2027-01-31.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 review.Batch review performed on 26-jul-2023: reverse shoulder system 04.01.0122 humeral reverse hc liner ø39/+0mm (k170452) lot 2118741: (b)(4) items manufactured and released on 20-jan-2022.Expiration date: 2027-01-09.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 review.Batch review performed on 26-jul-2023: reverse shoulder system 04.01.0155 glenoid baseplate ø27x25 (k170452) 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 with no similar reported case during the period of review.Batch review performed on 26-jul-2023: reverse shoulder system 04.01.0173 glenosphere 39xø27 (k170452) lot.2003895: (b)(4) items manufactured and released on 12-may-2021.Expiration date: 2026-04-28.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 review.
Additional Manufacturer Narrative
Addiitional devices received: reverse shoulder system 04.01.0162 glenoid polyaxial locking screw - l34 (k170452) lot 2118707.Reverse shoulder system 04.01.0162 glenoid polyaxial locking screw - l34 (k170452) lot 2115027.Batch review performed on 11-sep-2023.Reverse shoulder system 04.01.0162 glenoid polyaxial locking screw - l34 (k170452) lot 2118707: 198 items manufactured and released on 21-feb-2022.Expiration date: 2027-02-07.No anomalies found related to the problem.To date, 182 items of the same lot have been sold with no similar reported case during the period of review.Reverse shoulder system 04.01.0162 glenoid polyaxial locking screw - l34 (k170452) lot 2115027: 222 items manufactured and released on 16-dec-2021.Expiration date: 2026-12-06.No anomalies found related to the problem.To date, 214 items of the same lot have been sold with no similar reported case during the period of review.Clinical evaluation performed by medical affairs department late infection in cementless rsa, 1 year and 2 months after primary operation.Infection is a known possible adverse event following every surgery, including rsa's.To date, there is no reason to suspect that the cause may be linked to the implanted devices.Visual inspection performed by r&d project manager.The explants do not show any anomalies.

• Brand Name: REVERSE SHOULDER SYSTEM SHORT HUMERAL DIAPHYSIS - CEMENTLESS - 10
• Common Device Name: SHOULDER DIAPHYSIS
• 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: 17404478
• Report Number: 3005180920-2023-00614
• Device Sequence Number: 5962497
• Product Code: PHX
• UDI-Device Identifier: 07630040715911
• UDI-Public: 07630040715911
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• PMA/510(K) Number: K180089
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2022
• Device Explanted Year: 2023
• 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): 09/18/2023

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: 08/19/2026
• Device Catalogue Number: 04.01.0183
• Device Lot Number: 2110753
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/11/2023
• Supplement Date Received by Manufacturer: 07/11/2023
• Initial Report FDA Received Date: 07/27/2023
• Supplement Report FDA Received Date: 09/18/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/02/2021
• 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: 70 YR
• Patient Sex: Male
• Patient Weight: 115 KG
• Patient Race: White