MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA STEM: MPRES STEM STD SIZE 3; HIP STEM

Catalog Number	01.37.003
Medical Device Problem Code	Osseointegration Problem (3003)
Health Effect - Clinical Code	Implant Pain (4561)
Date of Event	09/09/2023
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Batch review performed on 15 september 2023.Lot 2106736: (b)(4) items manufactured and released on 16-dic-2021.Expiration date: 2026-12-02.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 department.Revision 6 months from the primary tha, due to stem loosening in a difficult primary case following femoral osteotomy.The surgeon probably tried to use a short stem in order to spare an additional straightening osteotomy, but the bone quality turned out to be low and was unable to sustain the short stem.
Event or Problem Description
At about 6 months from the primary, the patient had an mpres stem revised due to ongoing thigh pain since primary operation.The cause of the pain was likely caused by a loose prosthesis as the stem was able to be removed by hand.
Additional Manufacturer Narrative
On the 15th of november 2023 we have received the items involved in the event.Visual inspection performed by r&d project manager: during the analysis it is evaluated that the whole stem body is covered with ha.None absorption of ha from the stem body can indicate that metabolic activity wasn't taking place and that, presumably, not adequate bone contact was achieved at the time of surgery.The post-op x-ray analysis could possibly provide more insight, such as the evaluation of possible early rotational instability or initial stress-shielding.Some signs of minor damage 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.We removed the head from the stem and no particularity have been found both on the stem taper and on the femoral head.Based on the analysis completed and information available, it is not possible to identify a root cause of the stem loosening reported.

• Brand Name: STEM: MPRES STEM STD SIZE 3
• 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: 17903362
• Report Number: 3005180920-2023-00767
• Device Sequence Number: 20777697
• Product Code: LZO
• UDI-Device Identifier: 07630345713353
• UDI-Public: 07630345713353
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• PMA/510(K) Number: K210263
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2023
• 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): 12/06/2023

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 Catalogue Number: 01.37.003
• Device Lot Number: 2106736
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/11/2023
• Supplement Date Received by Manufacturer: 09/11/2023
• Initial Report FDA Received Date: 10/10/2023
• Supplement Report FDA Received Date: 12/06/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 12/16/2021
• 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: 42 YR
• Patient Sex: Female
• Patient Weight: 90 KG
• Patient Race: White