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

Model Number	01.18.432
Health Effect - Clinical Code	Unspecified Infection (1930)
Date of Event	10/29/2021
Type of Reportable Event	Serious Injury
Event or Problem Description
The patient came in reporting pain due to a potted stem and due to signs of an infection.The cause of the potted stem is infection and the pathogen is unknown.About 2 weeks after the primary surgery, the surgeon performed a washout and revised the stem, head, and liner.The surgery was completed successfully.
Additional Manufacturer Narrative
Batch review performed on 2 november 2021.Lot 2000071: (b)(4).Expiration date: 2025-may-18.No anomalies found related to the problem.(b)(4).Additional items involved in the event, batch review performed on 02 november 2021 liner: versafitcup dm 01.26.2848mhc double mobility hc liner ø 48/28 (k092265) lot.2103095.Lot 2103095: (b)(4).Expiration date: 2026-apr-13.No anomalies found related to the problem.(b)(4).Ball heads: mectacer 01.29.201 biolox delta ceramic ball head 12/14 ø 28 size s -3.5 (k112115) lot.2101448.Lot 2101448: (b)(4).Expiration date: 2026-may-05.No anomalies found related to the problem.(b)(4).

• Brand Name: STEM: AMISTEM-P COLLARED AMISTEM-P COLLARED STD STEM 2
• Common Device Name: 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: 12877898
• Report Number: 3005180920-2021-00922
• Device Sequence Number: 14561438
• Product Code: LZO
• UDI-Device Identifier: 07630040720212
• UDI-Public: 07630040720212
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K173794
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2021
• Device Explanted Year: 2021
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Other
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 11/26/2021

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: 05/18/2025
• Device Model Number: 01.18.432
• Device Catalogue Number: 01.18.432
• Device Lot Number: 2000071
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/29/2021
• Initial Report FDA Received Date: 11/26/2021
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 05/28/2020
• 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 Sex: Female