MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA STEM: AMISTEM C CEMENTED STD STEM SIZE 3; HIP CEMENTED STEM

Model Number	01.18.153
Health Effect - Clinical Code	Joint Disorder (2373)
Date of Event	01/20/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Batch review performed on 30 january 2020.Lot 160648: (b)(4) items manufactured and released on 14-mar-2016.Expiration date: 2021-02-27.No anomalies found related to the problem.To date, (b)(4) items of the same lot have been already sold without any other similar reported event.Clinical evaluation: less than 2 years after primary hybrid tha the femoral stem is found loose and replaced.The causes for loosening are unknown.The radiographs supplied show several points of separation between cement and stem and the bone has cavitary defects and low density.We do not know the history of this case as no former radiographs are available, in particular postoperative images were not supplied.Loosening of a cemented stem less than two years after index surgery is a very rare occurrence but we did not find any clue to suggest the reason for this case.No hints of a defective device were found in the information supplied.
Event or Problem Description
The patient came in reporting pain due to a loose stem.The cause of the loose stem is unknown.The surgeon revised the head, stem, and liner almost 1 year and 9 months after primary.The surgery was completed successfully.

• Brand Name: STEM: AMISTEM C CEMENTED STD STEM SIZE 3
• Common Device Name: HIP CEMENTED STEM
• Manufacturer (Section D): MEDACTA INTERNATIONAL SA; strada regina; castel san pietro, 6874 ; SZ 6874
• MDR Report Key: 9727247
• Report Number: 3005180920-2020-00066
• Device Sequence Number: 2500464
• Product Code: LZO
• UDI-Device Identifier: 07630030804281
• UDI-Public: 07630030804281
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K103189
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2018
• Device Explanted Year: 2020
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 02/19/2020

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: 02/27/2021
• Device Model Number: 01.18.153
• Device Catalogue Number: 01.18.153
• Device Lot Number: 160648
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/20/2020
• Initial Report FDA Received Date: 02/19/2020
• 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