MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA STEM: AMISTEM C CEMENTED STD STEM SIZE 0; CEMENTED HIP STEM

Model Number	01.18.150
Medical Device Problem Code	Loosening of Implant Not Related to Bone-Ingrowth (4002)
Health Effect - Clinical Code	Failure of Implant (1924)
Date of Event	10/29/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Batch review performed on 02 november 2021: lot 157553: (b)(4) items manufactured and released on 20-jan-2016.Expiration date: 2021-01-06.No anomalies found related to the problem.To date, all the items of the same lot have been sold without any similar reported event since 1-jan-2017.Clinical evaluation performed by medical affairs manager: partial hip revision surgery (stem, head and liner) performed 5 years after primary hybrid total hip arthroplasty in an heavy ((b)(6) kg) (b)(6) year old man.According to the report the patient reported pain.Ct images are not available.The origin of pain is unknown and no conclusion can be drawn on the basis of elements at hand.Preliminary investigation performed by r&d project manager: looking at the photo attached to the complaint it is visible expianted stem with some bloods residuals on the body surface.Some signs and scratches are present on the body and neck part probably due to revision surgery.It is not possible to determine the root cause of reported stem loosening.
Event or Problem Description
Revision surgery performed 5 years and 2 months after primary due to stem loosening.Stem, plug, head and liner revised successfully.

• Brand Name: STEM: AMISTEM C CEMENTED STD STEM SIZE 0
• Common Device Name: CEMENTED 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: 12878012
• Report Number: 3005180920-2021-00920
• Device Sequence Number: 17251835
• Product Code: LZO
• UDI-Device Identifier: 07630030804250
• UDI-Public: 07630030804250
• Combination Product (Y/N): N
• Initial Reporter Country: SZ
• PMA/510(K) Number: K103189
• 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): 11/26/2021

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: 01/06/2021
• Device Model Number: 01.18.150
• Device Catalogue Number: 01.18.150
• Device Lot Number: 157553
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/29/2021
• Initial Report FDA Received Date: 11/26/2021
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 01/20/2016
• 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 Age: 61 YR
• Patient Sex: Male
• Patient Weight: 117 KG