MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA SOLID SMS STEM LAT SIZE 7; FEMORAL STEM

Model Number	01.36.067
Health Effect - Clinical Code	Inadequate Osseointegration (2646)
Date of Event	06/18/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Batch review performed on 12 may 2021: lot 2000847: (b)(4) items manufactured and released on 15-may-2020.Expiration date: 2025-05-06.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 performed by medacta medical affairs department: few months after pèirimary cementless tha the patient reports some pain and the radiographs show a stem subsided by approximately 2 mm.It is very likely that the stem will now find final seating and the pain hopefully will go away.A subsiding stem may be due to undersizing but it can also be part of the physiological final seating phase.No revision was undertaken and the chances that it will not be needed are good.A total subsidence of 2 mm will probably be subclinical, if it stops, which seems very likely at this stage with the little information at hand.
Event or Problem Description
The patient came in reporting pain due to a subsided stem 5 months after the primary surgery.A revision surgery has not been scheduled at this time.More details to follow once a revision surgery takes place.
Event or Problem Description
The patient came in reporting pain due to a subsided stem and the cause of the subsided stem is unknown.7 months after the primary surgery the surgeon revised the stem and head with competitor implants and the surgery was completed successfully.

• Brand Name: SOLID SMS STEM LAT SIZE 7
• Common Device Name: FEMORAL STEM
• Manufacturer (Section D): MEDACTA INTERNATIONAL SA; strada regina; castel san pietro, 6874 ; SZ 6874
• MDR Report Key: 11848754
• Report Number: 3005180920-2021-00394
• Device Sequence Number: 11569207
• Product Code: LZO
• UDI-Device Identifier: 07630030888793
• UDI-Public: 07630030888793
• 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: 2020
• Device Explanted Year: 2021
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 07/08/2021

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: 05/06/2025
• Device Model Number: 01.36.067
• Device Catalogue Number: 01.36.067
• Device Lot Number: 2000847
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/19/2021
• Supplement Date Received by Manufacturer: 04/19/2021
• Initial Report FDA Received Date: 05/19/2021
• Supplement Report FDA Received Date: 07/08/2021
• 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: Other; Required Intervention
• Patient Age: 64 YR