MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA STEM: QUADRA-S CEMENTLESS, SAND BLASTED STD STEM SIZE 5; HIP CEMENTLESS STEM

Catalog Number	01.12.005
Medical Device Problem Code	Device Appears to Trigger Rejection (1524)
Health Effect - Clinical Codes	Unspecified Infection (1930); Medical device site infection (4845)
Date of Event	06/12/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
Revision surgery for hip infection on the (b)(6) 2024, date of primary is unknown.All devices revised successfully.Head and liner references and lot are unknown.
Additional Manufacturer Narrative
Batch review performed on 1 july 2024.Lot 100299: (b)(4) items manufactured and released on 22-mar-2010.Expiration date: 2015-15-02.No anomalies found related to the problem.To date, all the items of the same lot have been sold with no similar reported event during the period of review.Additional implant revised.Batch review performed on 1 july 2024 on cup: versafitcup cc trio 01.26.56mbt acetabular shell cc ø 56 () lot.100344.Lot 100344: (b)(4) items manufactured and released on 14-may-2010.Expiration date: 2015-30-04.No anomalies found related to the problem.To date, (b)(4) items of the same lot have been sold with no similar reported event during the period of review.Device not marketed in us.
Additional Manufacturer Narrative
The ceramic supplier on (b)(6) 2025: the component properties and the microstructure as obtained from the quality documents fulfil the requirements as specified at the time of production.There is no indication of any pre-existing material defect or non-conformities regarding sterilisation.Visual inspection performed by medacta hip r&d project managers: femoral components.Looking at the explanted stem body some signs of minor damage and scratches are present on boh the neck and the body of the explanted stem, which is likely due to the revision surgery and not relevant to the reported issue.The root cause of implant failure is unknown.Acetabular components: a visible dirt part tissue, maybe infected tissue, was noticed between the liner and cup.From the received parts it is not possible to determine the root cause of the event.Additional components involved (from competitors): implants from ceramtec 38.49.7179.275.00 biolox delta ceramic ball head 12/14 ø 36 size s - 4 lot.640710.Implants from ceramtec 38.49.7188.545.20 ceramic liner ø 36 / e lot.640064.Parts modified/added: b5, d9 and h3, visual inspection, supplier analysis (document review).
Event or Problem Description
Revision surgery for hip infection on (b)(6) 2024, date of primary is unknown but it was in 2010.All devices revised successfully.

• Brand Name: STEM: QUADRA-S CEMENTLESS, SAND BLASTED STD STEM SIZE 5
• Common Device Name: HIP CEMENTLESS 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: 19790170
• Report Number: 3005180920-2024-00539
• Device Sequence Number: 4148953
• Product Code: JDI
• UDI-Device Identifier: 07630030801860
• UDI-Public: 07630030801860
• Combination Product (Y/N): N
• Initial Reporter Country: IT
• PMA/510(K) Number: K072857
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Explanted Year: 2024
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 02/14/2025

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: 02/15/2015
• Device Catalogue Number: 01.12.005
• Device Lot Number: 100299
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/19/2024
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 07/22/2024
• Supplement Report FDA Received Date: 02/14/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/22/2010
• 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: 76 YR
• Patient Sex: Unknown