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

Catalog Number	01.18.404
Health Effect - Clinical Code	Unspecified Infection (1930)
Date of Event	10/09/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Batch review performed on 15 october 2019.Lot 178169: 70 items manufactured and released on 22-mar-2018.Expiration date: 2023-03-14.No anomalies found related to the problem.To date, 63 items of the same lot have been already sold without any other similar reported event.Additional implants involved in the event, batch review performed on (b)(6) 2019.Liner: mpact 01.32.3248hct flat pe hc liner ø32/f (k103721) lot.177538.Lot 177538: 30 items manufactured and released on 21-mar-2018.Expiration date: 2023-03-04.No anomalies found related to the problem.To date, 26 items of the same lot have been already sold without any other similar reported event.Cup: mpact 01.32.156dh acetabular shell ø56 two-holes (k132879) lot.179165 lot 179165: 71 items manufactured and released on 13-apr-2018.Expiration date: 2023-04-03.No anomalies found related to the problem.To date, 67 items of the same lot have been already sold without any other similar reported event.Ball heads: mectacer 01.29.206 biolox delta ceramic ball head 12/14 ø 32 size l +4 (k112115) lot.179843.Lot 179843: 141 items manufactured and released on 03-may-2018.Expiration date: 2023-04-18.No anomalies found related to the problem.To date, 120 items of the same lot have been already sold with another similar reported event.
Event or Problem Description
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 almost 1 year and 3 months after primary.The surgery was completed successfully.

• Brand Name: STEM: AMISTEM P STD STEM SIZE 4
• Common Device Name: CEMENTLESS STEM
• Manufacturer (Section D): MEDACTA INTERNATIONAL SA; strada regina; castel san pietro, 6874 ; SZ 6874
• MDR Report Key: 9283659
• Report Number: 3005180920-2019-00941
• Device Sequence Number: 2171846
• Product Code: LZO
• UDI-Device Identifier: 07630040720038
• UDI-Public: 07630040720038
• 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: 2018
• 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): 11/06/2019

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?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/09/2019
• Initial Report FDA Received Date: 11/06/2019
• 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: 45 YR