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

Catalog Number	01.18.434
Health Effect - Clinical Code	Unspecified Infection (1930)
Date of Event	04/05/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Batch review performed on 30 april 2019: lot 178147: (b)(4) items manufactured and released on 21-mar-2018.Expiration date: 2023-03-12.No anomalies found related to the problem.To date, (b)(4) items of the same lot have been already sold with another similar reported event (mdr 2019-00292).Other devices involved in the complaint ball heads: bipolar head 25060.2854 bipolar head ø28x54 lot.147799 (k091967): (b)(4) items manufactured and released on 25-feb-2015.Expiration date: 2020-01-31.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.Ball heads: mectacer 01.29.202 biolox delta ceramic ball head 12/14 ø 28 size m 0 lot.173282 (k112115): (b)(4) items manufactured and released on 31-oct-2017.Expiration date: 2022-10-15.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
Revision surgery performed after 25 days from the primary due to signs of infection (the pathogen is unknown).The surgeon washed out the hip and revised the stem, biolox head, and bipolar head.The surgery was completed successfully.

• Brand Name: STEM: AMISTEM P COLLARED STD STEM SIZE 4
• Common Device Name: HIP STEM CEMENTLESS
• Manufacturer (Section D): MEDACTA INTERNATIONAL SA; strada regina; castel san pietro, switzerland 6874 ; SZ 6874
• MDR Report Key: 8577874
• Report Number: 3005180920-2019-00338
• Device Sequence Number: 1837006
• Product Code: LZO
• UDI-Device Identifier: 07630040720236
• UDI-Public: 07630040720236
• Combination Product (Y/N): N
• Initial Reporter State: IL
• Initial Reporter Country: US
• PMA/510(K) Number: K173794
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2019
• Device Explanted Year: 2019
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 05/03/2019

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: 03/12/2023
• Device Catalogue Number: 01.18.434
• Device Lot Number: 178147
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/05/2019
• Initial Report FDA Received Date: 05/03/2019
• 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