MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA REVERSE SHOULDER SYSTEM HUMERAL REVERSE HC LINER 39/+6MM; SHOULDER REVERSE LINER

Model Number	04.01.0124
Health Effect - Clinical Code	Joint Dislocation (2374)
Date of Event	08/06/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Batch review performed on 10 august 2020: lot 1907768: (b)(4) items manufactured and released on 07-nov-2019.Expiration date: 2024-10-18.No anomalies found related to the problem.To date, (b)(4) items of the same lot have been already sold without any similar reported event.Additional device involved: batch review performed on 10 august 2020: reverse shoulder system 04.01.0211 lat.Glenosphere 39xø27 (k193175) lot 189947: (b)(4) items manufactured and released on 15-may-2019.Expiration date: 2024-04-30.No anomalies found related to the problem.To date, (b)(4) items of the same lot have been already sold without any similar reported event.Clinical evaluation performed by medacta medical affairs director: same-day dislocation of a reverse shoulder arthroplasty.The components remained intact and we cannot detect any hint of a defect that led to the problem.These events may be due to insufficient re-establishment of soft tissue tension after the operation or to accidental exaggerated movements performed by the patient when soft tissues are still sore post-surgery.No further conclusion can be drawn with the elements at hand.
Event or Problem Description
The patient had a primary surgery on the (b)(6) 2020.On the (b)(6) 2020 a revision surgery for unknown reason was necessary.On the (b)(6) 2020 (2 months after primary and 1 one after the first revision) the patient shoulder was revised again for dislocation of the glenosphere from the liner.The surgeon revised successfully the glenosphere, the liner and the methaphysis.

• Brand Name: REVERSE SHOULDER SYSTEM HUMERAL REVERSE HC LINER 39/+6MM
• Common Device Name: SHOULDER REVERSE LINER
• Manufacturer (Section D): MEDACTA INTERNATIONAL SA; strada regina; castel san pietro, 6874 ; SZ 6874
• MDR Report Key: 10487361
• Report Number: 3005180920-2020-00564
• Device Sequence Number: 2552986
• Product Code: PHX
• UDI-Device Identifier: 07630040706315
• UDI-Public: 07630040706315
• Combination Product (Y/N): N
• Initial Reporter Country: IT
• PMA/510(K) Number: K170452
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2020
• Device Explanted Year: 2020
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 09/03/2020

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: 10/18/2024
• Device Model Number: 04.01.0124
• Device Catalogue Number: 04.01.0124
• Device Lot Number: 1907768
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/06/2020
• Initial Report FDA Received Date: 09/03/2020
• 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
• Patient Age: 56 YR
• Patient Weight: 80