MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA STEM: AMISTEM H HA COATED LAT STEM SIZE 5; UNCEMENTED HIP STEM

Catalog Number	01.18.145
Health Effect - Clinical Code	Unspecified Infection (1930)
Date of Event	06/28/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Batch review performed on 11 july 2019: lot 173449: (b)(4) items manufactured and released on 10-november-2017.Expiration date: 2022-10-30.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.Additional devices involved.Batch reviews performed on 11 july 2019: ball heads: mectacer 01.29.211 biolox delta ceramic ball head 12/14 ø 36 size xl +8 (k112115).Lot 167394: (b)(4) items manufactured and released on 13-feb-2017.Expiration date: 2022-02-02.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.Liner: mpact 01.32.3648hct flat pe hc liner ø36/f (k103721).Lot 182616: (b)(4) items manufactured and released on 10-july-2018.Expiration date: 2023-06-25.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.Mpact 01.31.55tp shell screw plug (k103721).Lot 184748: (b)(4) items manufactured and released on 27-june-2018.Expiration date: 2023-06-03.Anomalies found related to the problem.To date, (b)(4) items of the same lot have been already sold with one other similar reported event.
Event or Problem Description
The surgeon found signs of an infection 1 year and 8 months after the primary.The patient is under pharmacological treatment.The revision surgery has not been performed yet.

• Brand Name: STEM: AMISTEM H HA COATED LAT STEM SIZE 5
• Common Device Name: UNCEMENTED HIP STEM
• Manufacturer (Section D): MEDACTA INTERNATIONAL SA; strada regina; castel san pietro, 6874 ; SZ 6874
• MDR Report Key: 8830119
• Report Number: 3005180920-2019-00619
• Device Sequence Number: 3079297
• Product Code: LZO
• UDI-Device Identifier: 07630030804212
• UDI-Public: 07630030804212
• Combination Product (Y/N): N
• Initial Reporter Country: IT
• PMA/510(K) Number: K093944
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2018
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 07/26/2019

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: 10/30/2022
• Device Catalogue Number: 01.18.145
• Device Lot Number: 173449
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/28/2019
• Initial Report FDA Received Date: 07/26/2019
• 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: 74 YR
• Patient Weight: 88