MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA STEM: MINIMAX CEMENTLESS ANATOMICAL STEM RIGHT SIZE 4; CEMENTLESS HIP STEM

Catalog Number	01.13.104R
Health Effect - Clinical Code	Unspecified Infection (1930)
Date of Event	04/17/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Batch review performed on 20 may 2019 lot 131797: (b)(4) items manufactured and released on 22 july 2013.Expiration date: 2018-06-30.No anomalies found related to the problem.To date, all the items of the same lot have been already sold with another similar reported event ((b)(4)).Additional component involved: lot 132206: (b)(4) items manufactured and released on 05-aug-2013.Expiration date: 2018-06-30.No anomalies found related to the problem.To date, all the items of the same lot have been already sold without any other similar reported event.Manufacturing process review performed by the manufacturer the event has been notified to the ceramic supplier on the 2 may 2019.On the 3 may 2019 ceramtec inserted the complaint in his system with code (b)(4).On the 3 may 2019 the ceramic supplier reported as follows: the component properties and the microstructure as obtained from the quality documents fulfil the requirements as specified at the time of production.There are no indications of any pre-existing material defect or non-conformities regarding sterilisation.Due to a lack of ceramic parts further investigations cannot be done.
Event or Problem Description
About 5 years and 5 months post primary the surgeon revised the patient for a suspected infection.Infection found at soft tissue level.The surgeon revised successfully all the components and implanted an antibiotic spacer [pathogen: staphylococcus aureus].

• Brand Name: STEM: MINIMAX CEMENTLESS ANATOMICAL STEM RIGHT SIZE 4
• Common Device Name: CEMENTLESS HIP STEM
• Manufacturer (Section D): MEDACTA INTERNATIONAL SA; strada regina; castel san pietro, 6874 ; SZ 6874
• MDR Report Key: 8623893
• Report Number: 3005180920-2019-00384
• Device Sequence Number: 2169133
• Product Code: LZO
• UDI-Device Identifier: 07630030803222
• UDI-Public: 07630030803222
• Combination Product (Y/N): N
• Initial Reporter Country: IT
• PMA/510(K) Number: K170845
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2013
• 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): 05/20/2019

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: 06/30/2018
• Device Catalogue Number: 01.13.104R
• Device Lot Number: 131797
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/20/2019
• Initial Report FDA Received Date: 05/20/2019
• 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: 66 YR
• Patient Weight: 78