MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA REVERSE SHOULDER SYSTEM HUMERAL REVERSE HC LINER Ø42/+6MM

Catalog Number	04.01.0127
Health Effect - Clinical Code	Joint Dislocation (2374)
Date of Event	04/30/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Batch review performed on 27 may 2019: lot 179122: (b)(4) items manufactured and released on 22-mar-2018.Expiration date: 2023-03-08.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 in the event: reverse shoulder system 04.01.0174 glenosphere 42x27 (k170452) lot.163806: (b)(4) items manufactured and released on 20-dec-2016.Expiration date: 2021-11-08.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.Clinical evaluation performed medical affairs manager: revision due to dislocation occurred 1 month after reverse total shoulder arthroplasty.The components remained intact and we cannot detect any hint of a defect that led to the problem.These events are normal 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)(4) 2019 we were informed of a shoulder dislocation, the glenosphere dislocated from the liner.The patient has been revised on (b)(6) 2019, after about 5 weeks from the primary surgery.
Additional Manufacturer Narrative
Visual inspection performed by medacta hip r&d project manager: the liner showed mild scratches on the outer chamfer and damages on the inferior surface of the cylinder likely due to the maneuvers for the removal from the reverse metaphysis.The glenosphere shows mild scratches on the articular surface.

• Brand Name: REVERSE SHOULDER SYSTEM HUMERAL REVERSE HC LINER Ø42/+6MM
• Common Device Name: HUMERAL REVERSE HC LINER
• Manufacturer (Section D): MEDACTA INTERNATIONAL SA; strada regina; castel san pietro, 6874 ; SZ 6874
• MDR Report Key: 8649825
• Report Number: 3005180920-2019-00409
• Device Sequence Number: 3030235
• Product Code: PHX
• UDI-Device Identifier: 07630040706346
• UDI-Public: 07630040706346
• 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): 10/17/2019

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: 03/08/2023
• Device Catalogue Number: 04.01.0127
• Device Lot Number: 179122
• 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: 04/29/2019
• Supplement Date Received by Manufacturer: 04/29/2019
• Initial Report FDA Received Date: 05/29/2019
• Supplement Report FDA Received Date: 10/17/2019
• 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: 57 YR
• Patient Weight: 85