MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA HUMERAL REVERSE METAPHYSIS +9MM/0°

Catalog Number	04.01.0111
Health Effect - Clinical Code	Joint Dislocation (2374)
Date of Event	11/20/2017
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Batch review performed on 14 december 2017.Lot 163788: (b)(4) items manufactured and released on 20 december 2016.Expiration date: 2021-11-02 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.Glenosphere 39xø27 reference 04.01.0173 (k170452): lot 163803: (b)(4) items manufactured and released on 20 december 2016.Expiration date: 2021-10-10 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.Humeral reverse hc liner ø39/+6mm reference reference 04.01.0124 (k170452) lot 163771: (b)(4) items manufactured and released on 20 december 2016.Expiration date: 2021-09-08 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 by medical affairs on 13 december 2017: dislocation of reverse shoulder arthroplasty 8 months after primary implantation.From the information received, the dislocation should be ascribed to a soft tissue deficiency.The implanted components did not mobilize nor did they fail in any way.This problem was not originated by a faulty device.
Event or Problem Description
Revision surgery was necessary due to luxation.

• Brand Name: HUMERAL REVERSE METAPHYSIS +9MM/0°
• Common Device Name: HUMERAL REVERSE METAPHYSIS
• Manufacturer (Section D): MEDACTA INTERNATIONAL SA; strada regina; castel san pietro, 6874 ; SZ 6874
• MDR Report Key: 7120560
• Report Number: 3005180920-2017-00752
• Device Sequence Number: 16440534
• Product Code: HSD
• UDI-Device Identifier: 07630040706186
• UDI-Public: 07630040706186
• Combination Product (Y/N): N
• Initial Reporter Country: SZ
• PMA/510(K) Number: K170452
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2017
• Device Explanted Year: 2017
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 12/15/2017

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: 11/02/2021
• Device Catalogue Number: 04.01.0111
• Device Lot Number: 163788
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/16/2017
• Initial Report FDA Received Date: 12/15/2017
• 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: 75 YR