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

Catalog Number	04.01.0001
Health Effect - Clinical Code	Joint Disorder (2373)
Date of Event	08/17/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Batch review performed by medacta regualtory affairs department on 13.Aug.2020: lot 1910855: (b)(4) items manufactured and released on 16-mar-2020.Expiration date: 2025-03-02.No anomalies found related to the problem.To date, (b)(4) items of the same lot have been already sold without any other similar reported event.Clinical evaluaton performed by medical affairs manager: revision surgery due to dislocation after reverse shoulder arthroplasty.These events are normally originated by insufficient re-establishment of soft tissue tension after the operation.No further conclusion can be drawn with the elements at hand.Additional implant involved: reverse shoulder system 04.01.0119 humeral reverse hc liner ø36/+0mm (k170452) lot.1910872.Batch review performed by medacta regualtory affairs department on 13.Aug.2020: lot 1910872: (b)(4) items manufactured and released on 06-mar-2020.Expiration date: 2025-02-22.No anomalies found related to the problem.To date, (b)(4) items of the same lot have been already sold without any other similar reported event.Additional implant involved: reverse shoulder system 04.01.0169 glenosphere 36xø24.5 (k170452) lot.1811894.Batch review performed by medacta regualtory affairs department on 13.Aug.2020: lot 1811894: (b)(4) items manufactured and released on 29-maz-2019.Expiration date: 2024-05-18.No anomalies found related to the problem.To date, (b)(4) items of the same lot have been already sold without any other similar reported event.
Event or Problem Description
The surgeon discovered the dislocation during a routine checkup at the x-ray 1 month after the primary surgery.The dislocation was caused by the subsidence of the stem (3mm below respect to the position during the primary surgery) probably caused by a technical error.The liner +0mm was revised with +3mm.
Additional Manufacturer Narrative
Batch review performed by medacta regulatory affairs department on 13.08.2020: lot 2000897: (b)(4) items manufactured and released on 6-may-2020.Expiration date: 2025-04-15.No anomalies found related to the problem.To date, (b)(4) items of the same lot have been already sold without any other similar reported event.Clinical evaluation: revision surgery due to dislocation after reverse shoulder arthroplasty.These events are normally originated by insufficient re-establishment of soft tissue tension after the operation.No further conclusion can be drawn with the elements at hand.
Event or Problem Description
Revision surgery performed due to dislocation caused by stem subsidence one month after the primary surgery.Probably the stem was inserted a bit too deeply during the primary surgery and also subsided after the primary surgery, what caused that the stem was finally 3mm below respect to the planned position.The liner +0mm was revised with +3mm.

• Brand Name: REVERSE SHOULDER SYSTEM SHORT HUMERAL DIAPHYSIS - CEMENTLESS - 10
• Common Device Name: CEMENTLESS HUMERAL DIAPHYSIS
• Manufacturer (Section D): MEDACTA INTERNATIONAL SA; strada regina; castel san pietro, 6874 ; SZ 6874
• MDR Report Key: 10493615
• Report Number: 3005180920-2020-00578
• Device Sequence Number: 2687551
• Product Code: PHX
• UDI-Device Identifier: 07630040715911
• UDI-Public: 07630040715911
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K180089
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2020
• 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): 10/06/2020

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: 03/02/2025
• Device Catalogue Number: 04.01.0001
• Device Lot Number: 2000897
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/05/2020
• Supplement Date Received by Manufacturer: 08/05/2020
• Initial Report FDA Received Date: 09/04/2020
• Supplement Report FDA Received Date: 10/06/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention