MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA REVERSE SHOULDER SYSTEM HUMERAL REVERSE HC LINER Ø42/+0MM; REVERSE SHOULDER HC LINER

Catalog Number	04.01.0125
Medical Device Problem Code	Device Dislodged or Dislocated (2923)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	04/17/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Batch review performed on 14 may 2019: lot 179982: (b)(4) items manufactured and released on 24-apr-2018.Expiration date: 2023-04-08.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 implant involved: reverse shoulder system 04.01.0174 glenosphere 42x27 (k170452) lot 179967: (b)(4) items manufactured and released on 03-may-2018.Expiration date: 2023-04-22.No anomalies found related to the problem.To date, (b)(4) items of the same lot have been already sold with another similar reported event (complaint (b)(4)).Clinical evaluation performed by medical affairs manager: polyethylene liner revision occurred 2 months after reverse total shoulder arthroplasty due to recurrent luxation.The components remained intact and we cannot detect any hint of a defect that led to the problem.These events are normally originated by progression of disease to the soft tissues or 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
On (b)(6) 2019 we were informed about a revision surgery performed on the following day due to implant luxation (glenosphere from the liner) 2 months after surgery, and deltoid damaging: a thicker inlay has been used in the revision.This is the second revision surgery for this patient that was revised firstly in (b)(6) 2019 due to an unknown reason.The primary surgery, the date is unknown, has been performed with non-medacta products.
Additional Manufacturer Narrative
Visual inspection performed by r&d project manager r&d analysis performed on (b)(6) 2019.The liner shows damages on the inferior surface of the cylinder likely due to the manoeuvres for the removal from the reverse metaphysis.

• Brand Name: REVERSE SHOULDER SYSTEM HUMERAL REVERSE HC LINER Ø42/+0MM
• Common Device Name: REVERSE SHOULDER HC LINER
• Manufacturer (Section D): MEDACTA INTERNATIONAL SA; strada regina; castel san pietro, 6874 ; SZ 6874
• MDR Report Key: 8615710
• Report Number: 3005180920-2019-00379
• Device Sequence Number: 11350086
• Product Code: PHX
• UDI-Device Identifier: 07630040706322
• UDI-Public: 07630040706322
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• PMA/510(K) Number: K170452
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2019
• Device Explanted Year: 2019
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 10/16/2019

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: 04/08/2023
• Device Catalogue Number: 04.01.0125
• Device Lot Number: 179982
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/17/2019
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/16/2019
• Supplement Date Received by Manufacturer: 04/16/2019
• Initial Report FDA Received Date: 05/16/2019
• Supplement Report FDA Received Date: 10/16/2019
• 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: 73 YR
• Patient Weight: 72