MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA REVERSE SHOULDER SYSTEM LONG HUMERAL DIAPHYSIS - L160 - 6; SHOULDER HUMERAL DIAPHYSIS

Model Number 04.01.0213

Device Problems Component Missing (2306); Loosening of Implant Not Related to Bone-Ingrowth (4002)

Patient Problem Pain (1994)

Event Date 06/17/2022

Event Type  Injury  

Event Description

At about 9 days after the primary surgery (of medacta products), the patient came in reporting pain due to a loose humeral diaphysis component and the cause is unknown.The surgeon revised the diaphysis, metaphysis, and liner.The surgery was completed successfully.The patient has a previous revision surgery of competitor's products: tornier reverse 6+ years post primary that was missing a large portion of the proximal humerus.

Manufacturer Narrative

Batch review performed on 28-jun-2022.Lot 1900924: (b)(4) items manufactured and released on 19-jul-2019.Expiration date: 2024-06-15.No anomalies found related to the problem.To date, (b)(4) items of the same lot have been sold with no similar reported case during the period of review.

• Brand Name: REVERSE SHOULDER SYSTEM LONG HUMERAL DIAPHYSIS - L160 - 6
• Type of Device: SHOULDER HUMERAL DIAPHYSIS
• Manufacturer (Section D): MEDACTA INTERNATIONAL SA; strada regina; castel san pietro, 6874 ; SZ 6874
• Manufacturer (Section G): MEDACTA INTERNATIONAL SA; strada regina; castel san pietro, 6874 ; SZ 6874
• Manufacturer Contact: stefano baj ; strada regina; castel san pietro, switzerland 6874 ; SZ 6874
• MDR Report Key: 15000061
• MDR Text Key: 295781303
• Report Number: 3005180920-2022-00527
• Device Sequence Number: 1
• Product Code: KWS
• UDI-Device Identifier: 07630040733922
• UDI-Public: 07630040733922
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K192967
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Company Representative
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 07/13/2022

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
• Device Operator: Health Professional
• Device Model Number: 04.01.0213
• Device Catalogue Number: 04.01.0213
• Device Lot Number: 1900924
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 06/17/2022
• Initial Date FDA Received: 07/13/2022
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 07/19/2019
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Sex: Female