MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA AMISTEM-P COLLARED; HIP STEM

Model Number	01.18.444
Medical Device Problem Code	Migration (4003)
Health Effect - Clinical Codes	Bone Fracture(s) (1870); Implant Pain (4561)
Date of Event	07/23/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
At about 1 month after primary, the patient has been revised because of periprosthetic femoral bone fracture.The surgeon revised successfully the stem and head and implanted a plate.It has been reported that, after the primary, the patient reported pain.During a checkup the stem was found to be subsided and the patient was maintained under observation.During the monitoring, a bone fracture was confirmed after traumatic event of the patient.Given the subsidence and pain after primary, it has hypothesized that an intra-op rib or minor fracture occurred.
Additional Manufacturer Narrative
Batch review performed on 14-aug-2024: lot 2339162: (b)(4) items manufactured and released on 05-dec-2023.Expiration date: 2028-11-19.No anomalies found related to the problem.To date, (b)(4) items of the same lot have been sold with no similar reported event during the period of review.Clinical evaluation performed by medical affairs director: a revision surgery was performed about 1 month after the implantation of a primary tha.The revision was necessitated by a peri-prosthetic femoral fracture associated with stem subsidence.Based on the available, poor quality post-operative x-rays image, the initial positioning and sizing of the stem appear to be fairly good.The follow-up x-rays image revelas clear subsidence of the stem and a fracture line at its distal part.It is reported that the subsidence occurred first, as the patient complained of pain shortly after returning home from the hospital, but opted to delay the revision surgery for observation.This issue may have been caused by the patient's bone quality or excessive load on the hip, given the patient's high weight.The reported cause of the subsequent fracture is trauma, as the patient accidentally fell at home.There is no evidence to suggest a defect or malfunction in the device.
Event or Problem Description
At about 1 month after primary, the patient has been revised because of periprosthetic femoral bone fracture.The surgeon revised successfully the stem and implanted a plate.It has been reported that, after the primary, the patient complained pain.During a checkup the stem was found to be subsided and the patient was maintained under observation.During the monitoring, a bone fracture was confirmed after traumatic event of the patient.
Additional Manufacturer Narrative
Clinical evaluation performed by medical affairs department.A revision surgery was performed about 1 month after the implantation of a primary tha.The revision was necessitated by a peri-prosthetic femoral fracture associated with stem subsidence.Based on the available poor quality post-operative x-rays image, the stem appears undersized.The follow-up x-rays image revelas clear subsidence of the stem and a fracture line at its distal part.It is reported that the subsidence occurred first, as the patient complained of pain shortly after returning home from the hospital but opted to delay the revision surgery for observation.This issue may have been caused by the undersizing of the stem, the patient's bone quality, and the patient's heavy weight.The reported cause of the subsequent fracture is trauma, as the patient accidentally fell at home.There is no evidence to suggest a defect or malfunction in the device.Additional modification that has been reported in this follow up 1: b3 "date of the event" has been changed from 19 july 2024 to 23 july 2024 b5 "event description" has been updated and corrected.D1 "brand name" has been corrected with the correct name amistem-p collared the reference, which was inserted in the field "catalog", has been reported in the correct field "model" in d4 d6b "date explanted" has been modified from (b)(6) 2024 h11 "additional manufacturer narrative", the updated and correct clinical evaluation has been inserted.

• Brand Name: AMISTEM-P COLLARED
• Common Device Name: HIP STEM
• Manufacturer (Section D): MEDACTA INTERNATIONAL SA; strada regina; castel san pietro, switzerland 6874 ; SZ 6874
• Manufacturer (Section G): MEDACTA INTERNATIONAL SA; strada regina; castel san pietro, switzerland 6874 ; SZ 6874
• Manufacturer Contact: marco giannessi ; strada regina; castel san pietro, switzerland 6874 ; SZ 6874
• MDR Report Key: 19981688
• Report Number: 3005180920-2024-00655
• Device Sequence Number: 8234749
• Product Code: LZO
• UDI-Device Identifier: 07630040720335
• UDI-Public: 07630040720335
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K173794
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2024
• Device Explanted Year: 2024
• 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): 10/23/2024

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 Model Number: 01.18.444
• Device Catalogue Number: 01.18.444
• Device Lot Number: 2339162
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/19/2024
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 08/14/2024
• Supplement Report FDA Received Date: 10/23/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 12/05/2023
• 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: 63 YR
• Patient Sex: Male
• Patient Weight: 101 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: Asian