MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA STEM: AMISTEM H HA COATED STD STEM SIZE 7; HIP CEMENTLESS STEM

Model Number	01.18.137
Health Effect - Clinical Codes	Unspecified Infection (1930); Joint Disorder (2373)
Date of Event	08/28/2017
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Batch review performed on 3 march 2020: lot 163102: (b)(4) items manufactured and released on 31-aug-2016.Expiration date: 2021-08-18.No anomalies found related to the problem.To date, (b)(4) items of the same lot have been already sold with another similar reported event.Clinical evaluation: late infection in cementless tha, 2.5 years after primary operation.Infection is a known possible adverse event following every surgery, including tha's.To date, there is no reason to suspect that the cause may be linked to the implanted devices.Other devices involved in the event: cup: versafitcup cc trio 01.26.45.1152 acetabular shell cc trio no-hole ø 52 lot.171705 ((b)(4)).Batch review performed on 3 march 2020: lot 171705: (b)(4) items manufactured and released on 9-june-2017.Expiration date: 2022-05-18.No anomalies found related to the problem.To date, (b)(4) items of the same lot have been already sold with another similar reported event.Liner: cc e cc light 01.26.3644hct flat pe hc liner ø 36 / e lot.171722 ((b)(4)).Batch review performed on 3 march 2020: lot 171722: (b)(4) items manufactured and released on 27-june-2017.Expiration date: 2022-06-07.No anomalies found related to the problem.To date, (b)(4) items of the same lot have been already sold with another similar reported event.Implants from ceramtec 38.49.7179.285.00 biolox delta ceramic ball head 12/14 ø 36 size m 0 lot.7011140767.Manufacturing process review: request for document review sent to the supplier ceramtec on 03.03.2020.Due to the lack of information about the laser engraving, the identification of the ball head is only possible based on the information provided by medacta.The ball head belongs to the shipping order (b)(4).Protocol and certificate of conformance were reviewed.The quality documents (including the sterilization certificates) show that the values obtained on the ball head were according to the specification valid at the time of production.The component properties and the microstructure as obtained from the quality documents fulfill the requirements as specified at the time of production.There are no indications of any pre-existing material defect or non-conformities regarding sterilization.Due to the lack of ceramic parts further investigations cannot be done.
Event or Problem Description
Revision surgery performed after 2 years and 6 months due to stem loosening.Initially, the stem was planned to be revised, but during the opening of the wound some purulence was discovered and because of that the surgeon decided to remove the entire prosthesis and implant a new hip.The infection is confirmed, the pathogen is pseudomonas aeruginosa.

• Brand Name: STEM: AMISTEM H HA COATED STD STEM SIZE 7
• Common Device Name: HIP CEMENTLESS STEM
• Manufacturer (Section D): MEDACTA INTERNATIONAL SA; strada regina; castel san pietro, 6874 ; SZ 6874
• MDR Report Key: 9826673
• Report Number: 3005180920-2020-00148
• Device Sequence Number: 14058917
• Product Code: LZO
• UDI-Device Identifier: 07630030804137
• UDI-Public: 07630030804137
• Combination Product (Y/N): N
• Initial Reporter Country: SZ
• PMA/510(K) Number: K093944
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2017
• Device Explanted Year: 2020
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 03/11/2020

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: 08/18/2021
• Device Model Number: 01.18.137
• Device Catalogue Number: 01.18.137
• Device Lot Number: 163102
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/14/2020
• Initial Report FDA Received Date: 03/12/2020
• 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
• Patient Age: 54 YR