MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA LINER: VERSAFITCUP CC TRIO FLAT PE HC LINER 28 / C

Model Number	01.26.2839HCT
Health Effect - Clinical Code	Unspecified Infection (1930)
Date of Event	05/13/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Batch review performed by medacta regulatory affairs department on 25 may 2020: lot 165409: (b)(4) items manufactured and released on 02-oct-2016.Expiration date: 2021-10-13.No anomalies found related to the problem.To date, (b)(4) items of the same lot have been already sold with no other similar reported event.Additional items involved in the event, batch review performed on 25 may 2020: cup: versafitcup cc trio 01.26.45.1148 acetabular shell cc trio no-hole 48 (k122911) lot.166745.Lot 166745: (b)(4) items manufactured and released on 06-feb-2017.Expiration date: 2022-01-26.No anomalies found related to the problem.To date, (b)(4) items of the same lot have been already sold with no other similar reported event.Stem: quadra-c 01.12.042 cemented, mirror polishing std stem size 2 12/14 (k083558) lot.168424 lot 168424: (b)(4) items manufactured and released on 05-apr-2017.Expiration date: 2022-03-12.No anomalies found related to the problem.To date, (b)(4) items of the same lot have been already sold with no other similar reported event.Implants from ceramtec 38.49.7175.455.00 biolox delta ceramic ball head 12/14 28 size m 0 lot.7011108288 (item not registered in usa, we have asked the batch review to the external supplier).
Event or Problem Description
The surgeon discovered an infection 3 years after the primary surgery (the pathogen is unknown) and decided to remove all implants.
Additional Manufacturer Narrative
On 16th of june 2020 the external supplier performed the batch review of the item reference 38.49.7175.455.00 biolox delta ceramic ball head 12/14 ø 28 size m 0 lot.7011108288 (item not registered in usa).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.

• Brand Name: LINER: VERSAFITCUP CC TRIO FLAT PE HC LINER 28 / C
• Common Device Name: FLAT PE HC LINER
• Manufacturer (Section D): MEDACTA INTERNATIONAL SA; strada regina; castel san pietro, 6874 ; CH 6874
• MDR Report Key: 10136934
• Report Number: 3005180920-2020-00317
• Device Sequence Number: 19412989
• Product Code: LZO
• UDI-Device Identifier: 07630030807091
• UDI-Public: 07630030807091
• Combination Product (Y/N): N
• Initial Reporter Country: SZ
• PMA/510(K) Number: K103352
• 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,Followup
• Report Date (Section B): 07/16/2020

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: 10/13/2021
• Device Model Number: 01.26.2839HCT
• Device Catalogue Number: 01.26.2839HCT
• Device Lot Number: 165409
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/13/2020
• Supplement Date Received by Manufacturer: 05/13/2020
• Initial Report FDA Received Date: 06/10/2020
• Supplement Report FDA Received Date: 07/16/2020
• 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: 84 YR
• Patient Weight: 87