MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA QUADRA-P STD STEM SIZE 2; HIP STEM

Catalog Number	01.12.122
Medical Device Problem Code	Device Appears to Trigger Rejection (1524)
Health Effect - Clinical Code	Medical device site infection (4845)
Date of Event	08/13/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Batch review performed on 23 august 2024: lot 2111495: (b)(4) manufactured and released on 14-dec-2021.Expiration date: 2026-11-24.No anomalies found related to the problem.To date, (b)(4) of the same lot have been sold without any similar reported event during the period of review.Additional implants involved; batch review performed on 23 august 2024: liner: mpact 01.26.2852mhc double mobility hc liner 28/dmf (k092265) lot 2402134: (b)(4) manufactured and released on 14-dec-2021.Expiration date: 2026-11-24.No anomalies found related to the problem.To date, (b)(4) of the same lot have been sold without any similar reported event during the period of review.Ball heads: mectacer 01.29.201 biolox delta ceramic ball head 12/14 ø 28 size s -3.5 (k112115) lot 2411634: (b)(4) manufactured and released on 10-may-2024.Expiration date: 2029-04-24.No anomalies found related to the problem.To date, (b)(4) of the same lot have been sold without any similar reported event during the period of review.Cup: mpact 01.32.152mb double mobility acetabular shell ø52 (k143453) lot 2402631: (b)(4) manufactured and released on 10-july-2024.Expiration date: 2029-04-24.No anomalies found related to the problem.To date, (b)(4) of the same lot have been sold without any similar reported event during the period of review.
Event or Problem Description
At about 4 days after the primary, the patient came in due to signs of infection and the pathogen is unknown.The surgeon revised all medacta hardware and reimplanted permanent product.The surgery was completed successfully.

• Brand Name: QUADRA-P STD STEM SIZE 2
• Common Device Name: HIP STEM
• Manufacturer (Section D): MEDACTA INTERNATIONAL SA; strada regina; castel san pietro, switzerland 6874 ; SZ 6874
• Manufacturer (Section G): MEDACTA INTERNATIONAL SA; strada regina; castel san pietro, switzerland 6874 ; SZ 6874
• Manufacturer Contact: marco giannessi ; strada regina; castel san pietro, switzerland 6874 ; SZ 6874
• MDR Report Key: 20167706
• Report Number: 3005180920-2024-00731
• Device Sequence Number: 15488381
• Product Code: LZO
• UDI-Device Identifier: 07630040720434
• UDI-Public: 07630040720434
• Combination Product (Y/N): N
• Initial Reporter State: MO
• Initial Reporter Country: US
• PMA/510(K) Number: K181254
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2024
• Device Explanted Year: 2024
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 09/09/2024

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 Catalogue Number: 01.12.122
• Device Lot Number: 2111495
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/13/2024
• Initial Report FDA Received Date: 09/09/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 12/14/2021
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 82 YR
• Patient Sex: Female