MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA STEM: AMISTEM P AMISTEM-P STD STEM SIZE 0; CEMENTESS HIP STEM

Model Number	01.18.400
Medical Device Problem Code	Osseointegration Problem (3003)
Health Effect - Clinical Codes	Pain (1994); Joint Laxity (4526)
Date of Event	10/27/2021
Type of Reportable Event	Serious Injury
Event or Problem Description
At 2 years and 7 months after the primary surgery, the patient came in reporting pain due to a loose stem and the cause of the loose stem is unknown.The surgeon revised the stem and head with competitor components and revised the medacta liner with a medacta liner.The surgery was completed successfully.
Additional Manufacturer Narrative
Batch review performed on 8.Nov.2021: lot 182519: (b)(4) items manufactured and released on 3-aug-2018.Expiration date: 2023-07-24.No anomalies found related to the problem, to date, (b)(4) items of the same lot have been sold without any other similar reported event.

• Brand Name: STEM: AMISTEM P AMISTEM-P STD STEM SIZE 0
• Common Device Name: CEMENTESS HIP STEM
• 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: 12851093
• Report Number: 3005180920-2021-00914
• Device Sequence Number: 4788187
• Product Code: LZO
• UDI-Device Identifier: 07630040719995
• UDI-Public: 07630040719995
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K173794
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2019
• Device Explanted Year: 2021
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 11/22/2021

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: 07/24/2023
• Device Model Number: 01.18.400
• Device Catalogue Number: 01.18.400
• Device Lot Number: 182519
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/27/2021
• Initial Report FDA Received Date: 11/22/2021
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 08/03/2018
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Female