MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA STEM SMS SOLID SMS SOLID STEM STD SIZE 7; HIP STEM CEMENTLESS

Model Number	01.36.047
Medical Device Problem Code	Migration or Expulsion of Device (1395)
Health Effect - Clinical Code	Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available (4581)
Date of Event	09/22/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Visual inspection performed by hip r&d project manager.During the analysis it is visible that the whole ha on the stem body is present, meaning that the stem was not osseointegrated with patient bone.Some signs and scratches are present on the stem neck probably due to revision surgery.A deep sign is present on the medial part of the stem neck close to the ha coating, probably due to revision surgery.It is not possible to determine the root cause of reported stem loosening.Batch review performed on 08 october 2021: lot 2004277: (b)(4) items manufactured and released on 10-july-2020.Expiration date: 2025-july-01.No anomalies found related to the problem.To date, (b)(4) items of the same lot have been sold without any similar reported event.
Event or Problem Description
Revision surgery 3 months after primary due to stem subsidence.Stem loosening, osteolysis and fracture were found on the femur.
Additional Manufacturer Narrative
Clinical evalutaion: 3 months after primary cementless tha the stem subsides and requires revision.According to the images supplied, of very low quality, a possible cause was the undersizing of the stem.We do not have enough information to understand the reasons that may have led the surgeon to undersize, if he did.There is no mention of traumatic events that may have led to femoral fractures, which are not visible in the low-quality pictures supplied.It is however rather evident that the subsidence took place almost immediately after surgery, thus indicating that primary stability was never achieved.An elderly patient may not have sufficiently good bone quality to allow a short cementless stem to become reliably stable.The approach used was the a mini posterior one.

• Brand Name: STEM SMS SOLID SMS SOLID STEM STD SIZE 7
• Common Device Name: HIP STEM CEMENTLESS
• 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: 12688347
• Report Number: 3005180920-2021-00830
• Device Sequence Number: 4012381
• Product Code: LZO
• UDI-Device Identifier: 07630030888663
• UDI-Public: 07630030888663
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• PMA/510(K) Number: K181693
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2021
• 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): 11/24/2021

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: 07/01/2025
• Device Model Number: 01.36.047
• Device Catalogue Number: 01.36.047
• Device Lot Number: 2004277
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/19/2021
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/28/2021
• Supplement Date Received by Manufacturer: 09/28/2021
• Initial Report FDA Received Date: 10/25/2021
• Supplement Report FDA Received Date: 11/24/2021
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/10/2020
• 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: 85 YR
• Patient Sex: Unknown
• Patient Weight: 74 KG