MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA STEM: SMS SOLID STEM STD SIZE 5; UNCEMENTED HIP STEM

Catalog Number	01.36.045
Health Effect - Clinical Code	Joint Disorder (2373)
Date of Event	09/03/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Batch review performed on (b)(6) 2019: lot 182330: (b)(4) items manufactured and released on 24-jul-2018.Expiration date: 2023-07-10.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.
Event or Problem Description
The patient came in, 3 months after primary surgery, complaining of pain due to a subsided stem.The cause of the subsided stem is unknown.The surgeon revised the medacta sms solid stem (b)(6) with a medacta minimax stem - size 5 left, and revised the medacta 36mm biolox delta head s with a medacta 36mm biolox delta head s.The surgery was completed successfully.

• Brand Name: STEM: SMS SOLID STEM STD SIZE 5
• Common Device Name: UNCEMENTED HIP STEM
• Manufacturer (Section D): MEDACTA INTERNATIONAL SA; strada regina; castel san pietro, 6874 ; SZ 6874
• MDR Report Key: 9144402
• Report Number: 3005180920-2019-00831
• Device Sequence Number: 2614994
• Product Code: LZO
• UDI-Device Identifier: 07630030888649
• UDI-Public: 07630030888649
• Combination Product (Y/N): N
• Initial Reporter State: IL
• Initial Reporter Country: US
• PMA/510(K) Number: K181693
• 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): 10/02/2019

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: 07/10/2023
• Device Catalogue Number: 01.36.045
• Device Lot Number: 182330
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/03/2019
• Initial Report FDA Received Date: 10/02/2019
• 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