MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA AMISTEM C CEMENTED STD STEM SIZE 0; CEMENTED HIP STEM

Catalog Number	01.18.150
Health Effect - Clinical Code	Unspecified Infection (1930)
Date of Event	11/11/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Batch review performed on 11 december 2018.Lot 154509: (b)(4) items manufactured and released on 11 september 2015.Expiration date: 2020-08-15.No anomalies found related to the problem.To date, (b)(4) items of the same lot have been already sold without any similar reported event.Others devices involved: mpact flat pe hc liner ø28/b, reference 01.32.2837hct.Lot 166648: (b)(4) items manufactured and released on 07 november 2016.Expiration date: 2021-10-25.No anomalies found related to the problem.To date, (b)(4) items of the same lot have been already sold without any similar reported event.Mpact acetabular shell ø46 two-holes, reference 01.32.146dh.Lot 168434: (b)(4) items manufactured and released on 09 march 2017.Expiration date: 2022-02-27.No anomalies found related to the problem.To date, 35 items of the same lot have been already sold without any similar reported event.Mectacer biolox delta ceramic ball head 12/14 ø 28 size s -3.5, reference 01.29.201.Lot 172246: (b)(4) items manufactured and released on 28 august 2017.Expiration date: 2022-08-17.No anomalies found related to the problem.To date, (b)(4) items of the same lot have been already sold without any similar reported event.
Event or Problem Description
About 11 months after primary the surgeon revised the patient for hip infection.Stem, head, cup and liner swap.The surgery was completed successfully.

• Brand Name: AMISTEM C CEMENTED STD STEM SIZE 0
• Common Device Name: CEMENTED HIP STEM
• Manufacturer (Section D): MEDACTA INTERNATIONAL SA; strada regina; castel san pietro, switzerland 6874 ; SZ 6874
• MDR Report Key: 8150505
• Report Number: 3005180920-2018-00982
• Device Sequence Number: 18906081
• Product Code: LZO
• UDI-Device Identifier: 07630030804250
• UDI-Public: 07630030804250
• Combination Product (Y/N): N
• Initial Reporter State: IL
• Initial Reporter Country: US
• PMA/510(K) Number: K103189
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2018
• Device Explanted Year: 2018
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 12/11/2018

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: 08/15/2020
• Device Catalogue Number: 01.18.150
• Device Lot Number: 154509
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/11/2018
• Initial Report FDA Received Date: 12/11/2018
• 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