MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA AMISTEM H 01.18.143 HA COATED LAT STEM SIZE 3 LOT. 166437; FEMORAL COMPONENT

Model Number	01.18.143
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	08/28/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Batch review performed on 31-august-2021: stem: amistem h 01.18.143 ha coated lat stem size 3 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 sold without any similar reported event.The documents related to the entire lot controls performed and to the raw materials used did not show any anomaly.Clinical evaluation performed by medical affairs director: fracture of the femoral stem in a primary cementless tha 2.5 years after surgery.The event is extremely rare, even more so after such a short period of time and in absence (according to the report) of further hip surgeries.The report does not mention anything that could help understanding the cause for the event.Analysis of the fractured components is essential and no conclusion can be drawn beforehand.Visual inspection performed by r&d joint director: it is not possible to establish a certain root cause of the event and it is preferable to send the item to an external laboratory.The stem was confirmed to be broken in the neck region, many scratches and signs of electrical knife are visible, it is not possible to confirm when they were performed without a specific analysis.Preliminary investigation preformed by r&d manager: looking at the images attached to the complaint it is visible that the neck of the stem is broken.Looking at the images attached it is not possible to determine the root cause of the breakage, the implant has to be inspected during the visula inspection phase.From the analysis of production route card no anomaly has been found in terms of material, diemnsions and production process.
Event or Problem Description
Revision surgery performed due to stem neck breakage, 2 years and 8 months after the primary surgery.The stem was replaced with a quadra r.No other revision surgeries have been performed with this patient.
Additional Manufacturer Narrative
External laboratory analysis report received on 26 november 2021.Conclusion: the failure of the prosthesis is actually covered with lots of surface damages that make a diagnosis of the root cause of failure difficult.The most relevant indication for an explanation of the failure is the huge reduction of area across the failure.Such a reduction of area can only be caused by a huge tensile overload before material separation started, i.E.With still fully integer prosthesis neck.From this follows, that the strong tensile overload caused either directly an incipient local crack (in the surface near area of origin 2, now heavily plastically deformed) or a sufficient pattern of slip bands inducing a protrusion on the external surface, able to allow a fatigue driven crack initiation (fatigue loads may have become more demanding due to the cross section reduction caused by the tensile overload).The mechanical damages covering now the surface of the prosthesis neck, including scratches, grooves, indentation and seizing marks, are related to the movement of the fractured or semi-fractured prosthesis components during their final permanence within the patient's body or were cause during the extraction surgery.A relevant role of the surface damages in the fatigue crack nucleation can be excluded, because the final rupture on the limited residual ligament (ca.30% of the fracture surface) could not have caused the reduction of area involving the whole neck cross-section.

• Brand Name: AMISTEM H 01.18.143 HA COATED LAT STEM SIZE 3 LOT. 166437
• Common Device Name: FEMORAL COMPONENT
• 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: 12525919
• Report Number: 3005180920-2021-00771
• Device Sequence Number: 4584500
• Product Code: LZO
• UDI-Device Identifier: 07630030804199
• UDI-Public: 07630030804199
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• PMA/510(K) Number: K093944
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2018
• Device Explanted Year: 2021
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 12/07/2021

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: 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
• Date Returned to Manufacturer: 09/21/2021
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/27/2021
• Supplement Date Received by Manufacturer: 08/27/2021
• Initial Report FDA Received Date: 09/24/2021
• Supplement Report FDA Received Date: 12/07/2021
• 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: 77 YR
• Patient Sex: Male