MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA AMISTEM H 01.18.143 HA COATED LAT STEM SIZE 3; HIP STEM

Model Number	01.18.143
Health Effect - Clinical Codes	Failure of Implant (1924); Pain (1994)
Date of Event	02/14/2022
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Batch review performed on 15 february 2022.Lot 166437: (b)(4) items manufactured and released on 28-feb-2017.Expiration date: 2022-02-12.No anomalies found related to the problem.To date, (b)(4) items of the same lot have been already sold without any similar reported event since 2018.
Event or Problem Description
The patient was under a lot of pain and there was no osseointegration.Stem and head were revised successfully 4 years and 3 months after primary.
Additional Manufacturer Narrative
Visual inspection performed by r&d manager: during the analysis it is visible that approximately half of the stem body is covered with ha coating meaning that the stem was not correctly osseointegrated with the patient bone.Some signs and scratches are present on the neck surface probably due to revision surgery.It is not possible to determine the root cause of incorrect stem osseointegration.

• Brand Name: AMISTEM H 01.18.143 HA COATED LAT STEM SIZE 3
• Common Device Name: 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: 13791072
• Report Number: 3005180920-2022-00169
• Device Sequence Number: 1661081
• Product Code: LZO
• UDI-Device Identifier: 07630030804199
• UDI-Public: 07630030804199
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• PMA/510(K) Number: K093944
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2017
• Device Explanted Year: 2022
• 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): 04/21/2022

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: 02/12/2022
• Device Model Number: 01.18.143
• Device Catalogue Number: 01.18.143
• Device Lot Number: 166437
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/14/2022
• Supplement Date Received by Manufacturer: 02/14/2022
• Initial Report FDA Received Date: 03/17/2022
• Supplement Report FDA Received Date: 04/21/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/28/2017
• 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: 89 YR
• Patient Sex: Male
• Patient Ethnicity: Non Hispanic
• Patient Race: White