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

Model Number 01.12.022

Device Problem Unintended Movement (3026)

Patient Problem Inadequate Osseointegration (2646)

Event Date 10/28/2021

Event Type  Injury  

Event Description

At 13 years after the primary, revision surgery was performed due to stem and cup mobilization.

Manufacturer Narrative

Batch review performed on 04 november 2021: lot 081892: (b)(4) items manufactured and released on 28-august-2008.Expiration date: 2013-06-30.No anomalies found related to the problem.To date, all items of the same lot have been sold without any similar reported event since 2017.Clinical evaluation performed by medical affairs director: 13 years after primary cementless tha an extensive radiolucent line surounds both stem and cup, and they both need revision.The tribological pairing was ceramic on ceramic, so pe debris cannot be suspected to have caused the reaction.The report does not mention infection but it does not give elements to exclude that a local inflammatory reaction took place: the situation is rather unusual, in absence of a subjective reactive process.No conclusion can be drawn to date as to the causes of this mobilization.Additional item involved in the event, batch review performed on 04 november 2021.Cup: versafitcup cc light 01.26.48mbtl acetabular shell cc light ø 48 lot.080023 (item not registered in usa).Lot 080023: (b)(4) items manufactured and released on 12-march-2008.Expiration date: 2013-01-31.No anomalies found related to the problem.To date, all items of the same lot have been sold without any similar reported event since 2017.Preliminary inspection performed by r&d project manager on the cup: the photo and received information does not provide any particular element to be used to determine the root cause of the event, as no particular signs are visible in the photo.

• Brand Name: STEM: QUADRA-H CEMENTLESS, HA COATED STD STEM SIZE 2
• Type of Device: CEMENTLESS HIP STEM
• Manufacturer (Section D): MEDACTA INTERNATIONAL SA; strada regina; castel san pietro, 6874 ; SZ 6874
• Manufacturer (Section G): MEDACTA INTERNATIONAL SA; strada regina; castel san pietro, 6874 ; SZ 6874
• Manufacturer Contact: stefano baj ; strada regina; castel san pietro, switzerland 6874 ; SZ 6874
• MDR Report Key: 12878086
• MDR Text Key: 281281036
• Report Number: 3005180920-2021-00917
• Device Sequence Number: 1
• Product Code: JDI
• UDI-Device Identifier: 07630030802034
• UDI-Public: 07630030802034
• Combination Product (y/n): N
• Reporter Country Code: SZ
• PMA/PMN Number: K082792
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Company Representative
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 11/26/2021

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
• Device Operator: Health Professional
• Device Expiration Date: 06/30/2013
• Device Model Number: 01.12.022
• Device Catalogue Number: 01.12.022
• Device Lot Number: 081892
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 10/28/2021
• Initial Date FDA Received: 11/26/2021
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 08/28/2008
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 79 YR
• Patient Sex: Female
• Patient Ethnicity: Non Hispanic
• Patient Race: White