MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA AMISTEM C CEMENTED STD STEM SIZE 4; CEMENTED STEM

Model Number	01.18.154
Health Effect - Clinical Code	Unspecified Infection (1930)
Date of Event	01/04/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Batch review performed on 31 january 2019.Lot 153924: (b)(4) items manufactured and released on 03 august 2015.Expiration date: 2020-07-15.No anomalies found related to the problem.To date, (b)(4) items of the same lot have been already sold without any similar reported event.Other devices involved: liner cc e cc light flat pe hc liner ø 32 / e reference 01.26.3244hct (k103352).Lot 152078: (b)(4) items manufactured and released on 07 july 2015.Expiration date: 2020-05-31.No anomalies found related to the problem.To date, (b)(4) items of the same lot have been already sold with 1 similar reported event.Versafitcup cc light acetabular shell cc light ø 54 reference 01.26.54mbtl (not marketed in us).Lot 115023: (b)(4) items manufactured and released on 09 february 2012.Expiration date: 2016-12-31.No anomalies found related to the problem.To date, all items of the same lot have been already sold without any similar reported event.Ceramic ball head reference 38.49.7175.675.00 (not marketed in us): the manufacturer was informed about the event.They reported: 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.Clinical evaluation performed by medical affairs manager on january 17, 2019 re-revision due to infection in hybrid tha, 3 years after first revision.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
About 6 years and a half after primary the surgeon revised the patient hip for an infection.All hardware revised.The surgery was completed successfully.
Additional Manufacturer Narrative
On february 21st 2020 we have received the item involved in the event.Visual inspection performed by r&d project manager: a year and a half after a successful primary total knee, the patient complaint on anterior knee pain, the surgeon decided to resurface the patella.With the aim of compensating a little flexion laxity, he had also decided to change the tibial insert, from 10mm to 12mm height.The visual inspection of the explanted tibial insert didn't highlight any discrepancy or any other aspect relevant for the event.With the information at hand, it is not possible to suppose that the event is related to a faulty device.

• Brand Name: AMISTEM C CEMENTED STD STEM SIZE 4
• Common Device Name: CEMENTED STEM
• Manufacturer (Section D): MEDACTA INTERNATIONAL SA; strada regina; castel san pietro, switzerland 6874 ; SZ 6874
• MDR Report Key: 8292561
• Report Number: 3005180920-2019-00019
• Device Sequence Number: 13852572
• Product Code: LZO
• UDI-Device Identifier: 07630030804298
• UDI-Public: 07630030804298
• Combination Product (Y/N): N
• Initial Reporter Country: SZ
• PMA/510(K) Number: K103189
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2012
• Device Explanted Year: 2019
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 03/23/2020

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: 07/15/2020
• Device Model Number: 01.18.154
• Device Catalogue Number: 01.18.154
• Device Lot Number: 153924
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/21/2020
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/04/2019
• Supplement Date Received by Manufacturer: 01/04/2019
• Initial Report FDA Received Date: 01/31/2019
• Supplement Report FDA Received Date: 03/23/2020
• 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: 71 YR
• Patient Weight: 90