MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA QUADRA-H CEMENTLESS, HA COATED STD STEM SIZE 2; CEMENTLESS HIP STEM

Catalog Number	01.12.022
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	01/24/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Batch review performed on 22 february 2019.Lot 140245: (b)(4) items manufactured and released on 07 april 2014.Expiration date: 2019-02-28.No anomalies found related to the problem.To date, all items of the same lot have been already sold without any similar reported event.Clinical evaluation performed by medical affairs director hip revision surgery occurred 4 years and 8 months after cementless total hip arthroplasty in a (b)(6) year old man.According to the report, patient was affected by osteoporosis.Radiographic image provided shows the presence of radiolucent lines in gruen zones 1 and 2, and the bone shows signs of anomaly, etiology unknown.Aseptic loosening is a possible literature described adverse event after cementless hip replacements.Poor bone quality and osteoporosis may have favoured the stem mobilization.However, the reason of this event cannot be determined.Preliminary investigation performed by r&d product manager femoral stem shows hydroxyapatite layer completely absorbed during in situ time.It is not possible to determine an implant-related failure root cause.
Event or Problem Description
About 4 years and half after primary the surgeon revised the patient hip for stem loosening.Stem swap.The surgery was completed successfully.

• Brand Name: QUADRA-H CEMENTLESS, HA COATED STD STEM SIZE 2
• Common Device Name: CEMENTLESS HIP STEM
• Manufacturer (Section D): MEDACTA INTERNATIONAL SA; strada regina; castel san pietro, switzerland 6874 ; SZ 6874
• MDR Report Key: 8361564
• Report Number: 3005180920-2019-00092
• Device Sequence Number: 1923907
• Product Code: JDI
• UDI-Device Identifier: 07630030802034
• UDI-Public: 07630030802034
• Combination Product (Y/N): N
• Initial Reporter Country: SZ
• PMA/510(K) Number: K082792
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2014
• Device Explanted Year: 2019
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 02/22/2019

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: 02/28/2019
• Device Catalogue Number: 01.12.022
• Device Lot Number: 140245
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/24/2019
• Initial Report FDA Received Date: 02/22/2019
• 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: 57 YR
• Patient Weight: 80