MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA QUADRA-H CEMENTLESS, HA COATED STEM SIZE 4; HIP CEMENTLESS STEM

Catalog Number	01.12.024
Health Effect - Clinical Code	Unspecified Infection (1930)
Date of Event	02/11/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Clinical evaluation performed by medical affairs department: late infection in cementless tha, 3 years and 10 months 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.Batch review performed on 12 march 2019: lot 146839: (b)(4) items manufactured and released on 23-jan-2015.Expiration date: 2019-12-31.No anomalies found related to the problem.To date, all the items of this lot have already been sold without any other similar event reported.Another device was involved in the complaint, details are reported here below: ball heads: mectacer 01.29.208 biolox delta ceramic ball head 12/14 ø 36 size s - 4, lot 148660 (k112115): (b)(4) items manufactured and released on 11-mar-2015.Expiration date: 2020-01-31.No anomalies found related to the problem.To date, (b)(4) items of this lot have already been sold without any other similar event reported.
Event or Problem Description
3 years and 10 months after primary surgery, revision surgery performed for infection ((b)(6)) likely causing stem loosening.The surgery was completed successfully.
Additional Manufacturer Narrative
Additional information received from sales agent on the 15 and 18 march 2019: i made an error in the previous usage information: i gave usage and previous surgery date for the wrong hip (the correct one is the left hip).The date of primary surgery was actually on (b)(6) 2018.Lot number of the stem we are sending back was 177560, still same product number: 01.12.024.We do not have the head, as it was discarded.Clinical evaluation performed by medical affairs manager following the receipt of the updated data: late infection in cementless tha, about 11 months 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.Visual inspection performed by r&d project manager: ha layer completely intact on the proximal region.Few scratches on the neck region probably due to extraction.
Event or Problem Description
About 1 year after primary surgery, revision surgery performed for infection (mrse) likely causing stem loosening.The surgery was completed successfully.Stem and head swap, the head is not available, neither the lot.

• Brand Name: QUADRA-H CEMENTLESS, HA COATED STEM SIZE 4
• Common Device Name: HIP CEMENTLESS STEM
• Manufacturer (Section D): MEDACTA INTERNATIONAL SA; strada regina; castel san pietro, switzerland 6874 ; SZ 6874
• MDR Report Key: 8416470
• Report Number: 3005180920-2019-00143
• Device Sequence Number: 19158427
• Product Code: JDI
• UDI-Device Identifier: 07630030802058
• UDI-Public: 07630030802058
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• PMA/510(K) Number: K082792
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2018
• 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): 04/09/2019

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: 02/22/2023
• Device Catalogue Number: 01.12.024
• Device Lot Number: 177560
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/27/2019
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/11/2019
• Supplement Date Received by Manufacturer: 02/11/2019
• Initial Report FDA Received Date: 03/13/2019
• Supplement Report FDA Received Date: 04/09/2019
• 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: 73 YR
• Patient Weight: 90