MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA STEM: AMISTEM H HA COATED LAT STEM SIZE 2; UNCEMENTED HIP STEM

Catalog Number	01.18.142
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 09-july-2019: lot 175338: (b)(4) items manufactured and released on 08-november-2017.Expiration date: 2022-10-24.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: batches review performed on 09-july-2019: cup: mpact 01.32.150dh acetabular shell ø50 two-holes (k132879) lot 188867: (b)(4) items manufactured and released on 27-february-2019.Expiration date: 2024-02-18.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 01.29.206 biolox delta ceramic ball head 12/14 ø 32 size l +4 (k112115) lot 188867: (b)(4) items manufactured and released on 27-february-2019.Expiration date: 2024-02-18.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 01.32.3241hct flat pe hc liner ø32/d (k103721) lot 1810216: (b)(4) items manufactured and released on 10-december-2018.Expiration date: 2023-11-28.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 1903028: (b)(4) items manufactured and released on 02-april-2019.Expiration date: 2024-03-13.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
The surgeon found signs of an infection one month after primary surgery.The patient is under pharmacological treatment.The revision surgery has not been performed yet.

• Brand Name: STEM: AMISTEM H HA COATED LAT STEM SIZE 2
• Common Device Name: UNCEMENTED HIP STEM
• Manufacturer (Section D): MEDACTA INTERNATIONAL SA; strada regina; castel san pietro, 6874 ; SZ 6874
• MDR Report Key: 8826048
• Report Number: 3005180920-2019-00618
• Device Sequence Number: 14097221
• Product Code: LZO
• UDI-Device Identifier: 07630030804182
• UDI-Public: 07630030804182
• 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: 2019
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 06/25/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 10/24/2022
• Device Catalogue Number: 01.18.142
• Device Lot Number: 175338
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/08/2017
• Initial Report FDA Received Date: 07/25/2019
• 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: 54 YR
• Patient Weight: 55