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

Catalog Number	01.18.434
Medical Device Problem Code	Device Appears to Trigger Rejection (1524)
Health Effect - Clinical Code	Unspecified Infection (1930)
Date of Event	05/07/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
Hip revision for infection and the pathogen is unknown.At about 3 months post primary the surgeon removed all implants and implanted an antibiotic spacer.The surgery was completed successfully.
Additional Manufacturer Narrative
Batch review performed on 13 may 2024.Lot 2011565: (b)(4) items manufactured and released on 03-feb-2021.Expiration date: 2026-01-24.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.Additional revised implants.Batch review performed on 13 may 2024 on ball heads: mectacer 01.29.212 biolox delta ceramic ball head 12/14 ø 40 size s - 4 (k112115) lot.2315558 lot 2315558: (b)(4) items manufactured and released on 05-july-2023.Expiration date: 2028-06-14.No anomalies found related to the problem.To date, (b)(4) items of the same lot have been sold with another similar event reported during the period of review.Batch review performed on 13 may 2024 on cup: mpact 01.32.156dh acetabular shell ø56 two-holes (k132879) lot.2306344.Lot 2306344: (b)(4) items manufactured and released on 02-aug-2023.Expiration date: 2028-07-13.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.Batch review performed on 13 may 2024 on liner: mpact 01.32.4048hct flat pe hc liner ø40/f (k122641) lot.2314080.Lot 2314080: (b)(4) items manufactured and released on 02-aug-2023.Expiration date: 2028-07-10.No anomalies found related to the problem.To date, (b)(4) items of the same lot have been sold with two other similar reported events during the period of review.
Additional Manufacturer Narrative
On 30 august 2024, a new complaint was opened by the branch.Analyzing the complaint, we recognized that this was an update of a previous reported complaint and it was also noted that this previous complaint was reported by the branch without the history of all previous revision surgeries.Event description and patient's details have been updated accordingly.
Event or Problem Description
The patient had a primary hip surgery on (b)(6) 2024.On (b)(6) 2024, the patient came in due to signs of an infection and the pathogen is unknown.The surgeon performed a washout and revised the head and liner.The surgery was completed successfully.On (b)(6) 2024, the patient came in due to signs of an infection and the pathogen is unknown.The surgeon performed a washout and revised the head and liner.The surgery was completed successfully.On (b)(6) 2024 the patient came in due to signs of an infection and the pathogen is unknown.The surgeon removed all implants and implanted an antibiotic spacer.The surgery was completed successfully.On (b)(6) 2024, antibiotic spacer was removed and final implants were implanted.

• Brand Name: STEM: AMISTEM-P COLLARED STD STEM SIZE 4
• Common Device Name: HIP COLLARED 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: 19465970
• Report Number: 3005180920-2024-00377
• Device Sequence Number: 7489310
• Product Code: LZO
• UDI-Device Identifier: 07630040720236
• UDI-Public: 07630040720236
• Combination Product (Y/N): N
• Initial Reporter State: MO
• Initial Reporter Country: US
• PMA/510(K) Number: K173794
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2024
• Device Explanted Year: 2024
• 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): 09/26/2024

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: 01/24/2026
• Device Catalogue Number: 01.18.434
• Device Lot Number: 2011565
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/07/2024
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 06/05/2024
• Supplement Report FDA Received Date: 09/26/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 02/03/2021
• 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: 71 YR
• Patient Sex: Male