MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA STEM: AMISTEM H HA COATED LAT STEM SIZE 4; CEMENTLESS HIP STEM

Catalog Number	01.18.144
Health Effect - Clinical Code	Unspecified Infection (1930)
Date of Event	10/04/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Batch review performed on 16 october 2019.Lot 147992: 35 items manufactured and released on 25-feb-2015.Expiration date: 2020-01-31.No anomalies found related to the problem.To date, 33 items of the same lot have been already sold without any other similar reported event.Additional implant involved: cup: versafitcup cc trio 01.26.45.1152 acetabular shell cc trio no-hole ø 52 (k122911) lot.150076.Batch review performed on 18 october 2019.Lot 150076 : 130 items manufactured and released on 12-may-2015.Expiration date: 2020-03-31.No anomalies found related to the problem.To date, 128 items of the same lot have been already sold without any other similar reported event.Additional implant involved: implants from ceramtec 38.49.7188.545.20 ceramic liner ø 36 / e lot.7010952302 (not distributed in the usa).Document review performed by the supplier ceramtec : due to the lack of information about the laser engraving the identification of the complained parts is only possible based on the information provided by medacta.The complained parts belong to the shop orders 7010944380(ball head) and 7010952302(insert).Protocols and certificates of conformance were reviewed.The quality documents (including the sterilization certificates) show that the values obtained on the ball head and insert were according to the specification valid at the time of production.The component properties and 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 defects or non-conformities regarding sterilization.Due to a luck of ceramic parts, further investigation cannot be done.Additional implant involved: implants from ceramtec 38.49.7179.275.00 biolox delta ceramic ball head 12/14 ø 36 size s - 4 lot.7010944380 (not distributed in the usa).Document review performed by the supplier ceramtec : due to the lack of information about the laser engraving the identification of the complained parts is only possible based on the information provided by medacta.The complained parts belong to the shop orders 7010944380 (ball head) and 7010952302 (insert).Protocols and certificates of conformance were reviewed.The quality documents (including the sterilization certificates) show that the values obtained on the ball head and insert were according to the specification valid at the time of production.The component properties and 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 defects or non-conformities regarding sterilization.Due to a luck of ceramic parts, further investigation cannot be done.Additional implant involved: stem: quadra -r 01.12.061 cementless, ha coated revision stem size (k082792) 1 lot.183887.Batch review performed on 6 november 2019: lot 183887: 10 items manufactured and released on 2-oct-2018.Expiration date: 2023-09-24.No anomalies found related to the problem.To date, 7 items of the same lot have been already sold without any other similar reported event.Additional implant involved: ball heads: mectacer 01.29.208 biolox delta ceramic ball head 12/14 ø 36 size s - 4 (k112115) lot.1900803 batch review performed on 6 november 2019: lot 1900803: 220 items manufactured and released on 15-mar-2019.Expiration date: 2024-05-04.No anomalies found related to the problem.To date, 165 items of the same lot have been already sold without any other similar reported event.Clnical evaluation performed by medical affairs manager.Late infection in cementless tha, 4.2 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.
Event or Problem Description
Revision surgery performed on (b)(6) 2019, 4 years and 2 months after the primary, due to sepsis.The stem and head were revised.After few days on (b)(6) 2019 all prosthesis has been removed due to continous sepsis.

• Brand Name: STEM: AMISTEM H HA COATED LAT STEM 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: 9284071
• Report Number: 3005180920-2019-00934
• Device Sequence Number: 1934568
• Product Code: LZO
• UDI-Device Identifier: 07630030804205
• UDI-Public: 07630030804205
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• PMA/510(K) Number: K093944
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2015
• 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): 11/06/2019

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: 01/31/2020
• Device Catalogue Number: 01.18.144
• Device Lot Number: 147992
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/08/2019
• Initial Report FDA Received Date: 11/06/2019
• 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: 55 YR
• Patient Weight: 75