MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA REVERSE SHOULDER SYSTEM STD HUMERAL DIAPHYSIS - CEMENTLESS - 11; HUMERAL DIAPHYSIS CEMENTLESS

Catalog Number	04.01.0006
Health Effect - Clinical Code	Joint Dislocation (2374)
Date of Event	04/30/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Batch review performed on 28 may 2018; lot 172245: (b)(4) items manufactured and released on 31 august 2017.Expiration date: 2022-07-23.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.Reverse shoulder system humeral reverse metaphysis +9mm/0° reference 04.01.0111 (k170452); lot 174655: (b)(4) items manufactured and released on 03 october 2017.Expiration date: 2022-09-11; 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.Reverse shoulder system humeral reverse hc liner ø39/+0mm reference 04.01.0122 (k170452); lot 173418: (b)(4) items manufactured and released on 03 july 2017.Expiration date: 2022-06-18 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.
Event or Problem Description
The patient came in complaining of pain 18 days after primary.The surgeon determined that the patient had dislocated.The cause of dislocation is unknown.The surgeon revised the diaphysis, metaphysis, and liner.The surgery was completed successfully.

• Brand Name: REVERSE SHOULDER SYSTEM STD HUMERAL DIAPHYSIS - CEMENTLESS - 11
• Common Device Name: HUMERAL DIAPHYSIS CEMENTLESS
• Manufacturer (Section D): MEDACTA INTERNATIONAL SA; strada regina; castel san pietro, switzerland 6874 ; SZ 6874
• MDR Report Key: 7552096
• Report Number: 3005180920-2018-00385
• Device Sequence Number: 11059586
• Product Code: PHX
• UDI-Device Identifier: 07630040706056
• UDI-Public: 07630040706056
• Combination Product (Y/N): N
• Initial Reporter State: IL
• Initial Reporter Country: US
• PMA/510(K) Number: K170452
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2018
• Device Explanted Year: 2018
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 05/30/2018

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: 07/23/2022
• Device Catalogue Number: 04.01.0006
• Device Lot Number: 172245
• 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: 04/30/2018
• Initial Report FDA Received Date: 05/30/2018
• 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: 61 YR