MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA GLENOSPHERE 42X27; REVERSE SHOULDER GLENOSPHERE

Catalog Number	04.01.0174
Health Effect - Clinical Code	Joint Dislocation (2374)
Date of Event	05/23/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
On 05 june 2019 the r&d project manager commented the retrieved pictures of the explanted devices: the implants do not present any signs of failure in the provided pictures.As stated in the event description, the dislocation is likely to be caused by instability.Batch review performed on 18 june 2019: lot 179115: (b)(4) items manufactured and released on 15 march 2018.Expiration date: 2023-03-05.No anomalies found related to the issue.To date, (b)(4) items of the same lot have been already sold without any similar reported event.Reverse shoulder system - humeral reverse hc liner ø42/+6mm, ref.04.01.0127, lot.179984 (k170452): batch review performed on 18 june 2019: lot 179984: (b)(4) items manufactured and released on 24 april 2018.Expiration date: 2023-04-09.No anomalies found related to the issue.To date, (b)(4) items of the same lot have been already sold without any similar reported event.On 19 june 2019 the medical affairs manager made the following analysis: recurrent dislocation during the first postoperative month.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
Second revision surgery performed due to glenosphere dislocation 1 month after the first revision.The dislocation happened during an exercise at the convalescence center (pendulum).The surgeon revised the glenosphere and the pe inlay to a +6 mm with the inclination of 155° instead of 145°.

• Brand Name: GLENOSPHERE 42X27
• Common Device Name: REVERSE SHOULDER GLENOSPHERE
• Manufacturer (Section D): MEDACTA INTERNATIONAL SA; strada regina; castel san pietro, 6874 ; SZ 6874
• MDR Report Key: 8722204
• Report Number: 3005180920-2019-00497
• Device Sequence Number: 1788091
• Product Code: PHX
• UDI-Device Identifier: 07630040706612
• UDI-Public: 07630040706612
• 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
• Report Date (Section B): 06/21/2019

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: 03/05/2023
• Device Catalogue Number: 04.01.0174
• Device Lot Number: 179115
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/23/2019
• Initial Report FDA Received Date: 06/21/2019
• 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