MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA STEM: AMISTEM C CEMENTED LAT STEM SIZE 4; CEMENTED HIP STEM

Model Number	01.18.104
Health Effect - Clinical Code	Unspecified Infection (1930)
Date of Event	04/30/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Batch review performed on 11 may 2020: lot 135642a: (b)(4) item manufactured and released on 02-may-2019.Expiration date: 2024-04-15.No anomalies found related to the problem.To date, (b)(4) item of the same lot have been already sold without any similar reported event.Additional implant invoved: ball heads: mectacer 01.29.210 biolox delta ceramic ball head 12/14 ø 36 size l + 4 (k112115) lot.1904653.Batch review performed on 11 may 2020: lot 1904653: (b)(4) items manufactured and released on 25-sep-2019.Expiration date: 2024-09-08.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.Additional implant invoved: cup: mpact 01.32.154dh acetabular shell ø54 two-holes (k132879) lot.1905338.Batch review performed on 11 may 2020: lot 1905338: (b)(4) items manufactured and released on 18-sep-2019.Expiration date: 2024-.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.Additional implant invoved: liner: mpact 01.32.3644hct acetabular shell ø54 two-holes (k103721) lot.1907432.Batch review performed on 11 may 2020: lot 1907432: (b)(4) items manufactured and released on 01-oct-2019.Expiration date: 2024-09-16.No anomalies found related to the problem.To date, (b)(4) items of the same lot have been already sold with one similar event reported.
Event or Problem Description
The patient came in, one month after primary surgery, due to signs of an infection and the pathogen is unknown.The surgeon performed a washout, removed all implants and revised the patient with new permanent hardware.The surgery was completed successfully.

• Brand Name: STEM: AMISTEM C CEMENTED LAT STEM SIZE 4
• Common Device Name: CEMENTED HIP STEM
• Manufacturer (Section D): MEDACTA INTERNATIONAL SA; strada regina; castel san pietro, 6874 ; SZ 6874
• MDR Report Key: 10100428
• Report Number: 3005180920-2020-00303
• Device Sequence Number: 3572881
• Product Code: LZO
• UDI-Device Identifier: 07630030803826
• UDI-Public: 07630030803826
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K103189
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2020
• Device Explanted Year: 2020
• Reporter Type: Manufacturer
• Report Source: other
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 05/29/2020

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: 04/15/2024
• Device Model Number: 01.18.104
• Device Catalogue Number: 01.18.104
• Device Lot Number: 135642A
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/30/2020
• Initial Report FDA Received Date: 05/29/2020
• 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