MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA STEM: AMISTEM COLLARED HA COATED STD SIZE 2; FEMORAL STEM CEMENTLESS

Model Number	01.18.232
Health Effect - Clinical Code	Inadequate Osseointegration (2646)
Date of Event	01/21/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Batch review performed on 28 january 2021: lot 161998: (b)(4) items manufactured and released on 20-june-2016.Expiration date: 2021-06-09.No anomalies found related to the problem.To date, (b)(4) items of the same lot have been already sold.No other similar reported event since 2017.Clinical evaluation performed by medacta medical affairs department: 4 years after primary cementless tha the stem subsides and revision is required.The pre-revision xray shows osteolytic damage quite extensively around the stem.Cause unknown.This clearly led to stem subsidence.The stem was originally placed very prominent from the femoral bone but it's unlikely that this is the cause of subsidence.The report does not mention infection.The root cause of this unfavourable bone reaction remains undetermined.
Event or Problem Description
The patient came in reporting pain due to a subsided stem 4 years 2 months after the primary.The cause of the subsided stem is unknown.The surgeon revised the stem and head with competitor products and revised the medacta liner with a medacta liner.The surgery was completed successfully.

• Brand Name: STEM: AMISTEM COLLARED HA COATED STD SIZE 2
• Common Device Name: FEMORAL STEM CEMENTLESS
• Manufacturer (Section D): MEDACTA INTERNATIONAL SA; strada regina; castel san pietro, 6874 ; SZ 6874
• MDR Report Key: 11347288
• Report Number: 3005180920-2021-00128
• Device Sequence Number: 4045145
• Product Code: LZO
• UDI-Device Identifier: 07630030804571
• UDI-Public: 07630030804571
• Combination Product (Y/N): N
• Initial Reporter State: IL
• Initial Reporter Country: US
• PMA/510(K) Number: K121011
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2016
• 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
• Report Date (Section B): 02/19/2021

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: 06/09/2021
• Device Model Number: 01.18.232
• Device Catalogue Number: 01.18.232
• Device Lot Number: 161998
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/21/2021
• Initial Report FDA Received Date: 02/19/2021
• 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: Required Intervention