MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA STEM: AMISTEM P AMISTEM- P SHORT NECK STD STEM SIZE 2; CEMENTLESS HIP STEM

Model Number 01.18.462

Device Problem Positioning Problem (3009)

Patient Problem Hip Fracture (2349)

Event Date 04/01/2022

Event Type  Injury  

Event Description

At 1 month after the primary surgery, during a follow-up visit, stem sinking associated with peri-stem fractures is observed.However, there were no complaints from the patient such as pain, and she was able to walk without problems.The patient reject the revision surgery, but the surgeon will continue to recommend revision surgery.Fracture lines may be seen on x-rays post-primary.It is unclear whether the operation of the rasps during the surgery was bad, but it may be due to the fact that the rasps were taken in and out many times during the surgery due to unfamiliar surgery.Bone quality is unknown.

Manufacturer Narrative

Batch review performed on 7 april 2022.Lot 2113027: 30 items manufactured and released on 15-feb-2022.Expiration date: 2027-feb-06.No anomalies found related to the problem.To date, 13 items of the same lot have been sold with no similar reported event.Clinical evaluation performed by clinical affairs specialist during a follow up visit few weeks after tha, it was noticed through radiographic images that the stem sinked and a fracture in the diaphyseal area was present.The sinking could have been caused by the fracture.The surgeon suggested a revision but since the patient did not report any pain she refused it.Intraoperative femoral fractures are known possible adverse events of total hip replacements, described and quantified in literature.They mainly depend on bone morphology and mechanical properties.In this case, there is no reason to suspect a malfunctioning device.

• Brand Name: STEM: AMISTEM P AMISTEM- P SHORT NECK STD STEM SIZE 2
• Type of Device: CEMENTLESS 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: 14267059
• MDR Text Key: 290551434
• Report Number: 3005180920-2022-00327
• Device Sequence Number: 1
• Product Code: LZO
• UDI-Device Identifier: 07630971243668
• UDI-Public: 07630971243668
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K192126
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Company Representative
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 05/02/2022

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
• Device Operator: Health Professional
• Device Model Number: 01.18.462
• Device Catalogue Number: 01.18.462
• Device Lot Number: 2113027
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 04/05/2022
• Initial Date FDA Received: 05/03/2022
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 02/15/2022
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 72 YR
• Patient Sex: Female
• Patient Ethnicity: Non Hispanic
• Patient Race: Asian