MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA AMISTEM H HA COATED LAT STEM SIZE 0; HIP CEMENTLESS STEM

Model Number	01.18.140
Medical Device Problem Code	Osseointegration Problem (3003)
Health Effect - Clinical Code	Inadequate Osseointegration (2646)
Date of Event	04/11/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
At about 7 years 5 months after the primary, revision surgery was performed due to stem loosening.Amistem h was revised to amistem-c stem and the surgery was completed successfully.
Additional Manufacturer Narrative
Batch review performed on 12 april 2023: lot 145422: (b)(4) items manufactured and released on 10-oct-2014.Expiration date: 2019-08-31.No anomalies found related to the problem.To date, all items of the same lot have been sold without any similar reported event during the period of review.
Additional Manufacturer Narrative
On (b)(6) 2023 we have received the x-rays and were analysed by the clinical affairs department: revision 7 years and 5 months after the primary tha, in a 69 year old female patient due to stem loosening.Amistem h was revised to amistem-c stem and the surgery was completed successfully.In the radiographic image, signs of stress shielding are visible.As no other radiographic images are available, we cannot reconstruct the history of this case, so we cannot determine if the stress shielding intervened subsequent to secondary stem subsidence or it was an early reaction of this patient to the prosthetic stem.On june 07th 2023 we have received the item involved in the event and has been analysed by the r&d project manager: looking at the stem body an opaque white film is visible on approximately half of the stem length.It is not possible to identify if this film is ha or bone residual, or a combined effect.Absorption of ha from the stem body can indicate that metabolic activity was taking place when adequate bone contact was achieved at the time of surgery.Some signs of minor damage (considering also burns) and scratches are present on the neck of the explanted stem, which is likely due to the revision surgery and not relevant to the reported issue.Based on the analysis completed and information available, it is not possible to identify a root cause of the stem loosening reported.

• Brand Name: AMISTEM H HA COATED LAT STEM SIZE 0
• Common Device Name: HIP CEMENTLESS 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: 16885913
• Report Number: 3005180920-2023-00317
• Device Sequence Number: 12297140
• Product Code: LZO
• UDI-Device Identifier: 07630030804168
• UDI-Public: 07630030804168
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K121011
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2015
• Device Explanted Year: 2023
• 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): 06/09/2023

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: 08/31/2019
• Device Model Number: 01.18.140
• Device Catalogue Number: 01.18.140
• Device Lot Number: 145422
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/11/2023
• Supplement Date Received by Manufacturer: 04/11/2023
• Initial Report FDA Received Date: 05/08/2023
• Supplement Report FDA Received Date: 06/09/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/10/2014
• 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: 69 YR
• Patient Sex: Female
• Patient Ethnicity: Non Hispanic
• Patient Race: Asian