MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA AMISTEM P AMISTEM-P STD STEM SIZE 4; HIP STEM

Catalog Number	01.18.404
Health Effect - Clinical Code	No Information (3190)
Date of Event	01/11/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Batch review performed on 11 february 2019: lot 178169: (b)(4) items manufactured and released on 22-mar-2018.Expiration date: 2023-03-14.No anomalies found related to the problem.To date, (b)(4) items of the same lot have been already sold without any other similar reported event.
Event or Problem Description
About 3 months after primary the surgeon revised the patient for stem subsidence.Stem revised successfully.
Additional Manufacturer Narrative
Visual inspection performed by r&d project manager visual inspection performed on 23rd september 2019.From the received part it was visible some fibrotic tissue on the entire body of the stem, suggesting a good bone-integration.There are no particular signs of the stem that could evidence a failure device and the root cause of the event is unknown.It is probable that an undersizing of the stem was performed.

• Brand Name: AMISTEM P AMISTEM-P STD STEM SIZE 4
• Common Device Name: HIP STEM
• Manufacturer (Section D): MEDACTA INTERNATIONAL SA; strada regina; castel san pietro, switzerland 6874 ; SZ 6874
• MDR Report Key: 8335140
• Report Number: 3005180920-2019-00049
• Device Sequence Number: 18845486
• Product Code: LZO
• UDI-Device Identifier: 07630040720038
• UDI-Public: 07630040720038
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• PMA/510(K) Number: K173794
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2018
• Device Explanted Year: 2019
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 10/17/2019

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: 03/14/2023
• Device Catalogue Number: 01.18.404
• Device Lot Number: 178169
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/15/2019
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/14/2019
• Supplement Date Received by Manufacturer: 01/14/2019
• Initial Report FDA Received Date: 02/13/2019
• Supplement Report FDA Received Date: 10/17/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 75 YR
• Patient Weight: 68