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
Health Effect - Clinical Code	Inadequate Osseointegration (2646)
Date of Event	10/28/2021
Type of Reportable Event	Serious Injury
Event or Problem Description
At 13 years after the primary, revision surgery was performed due to stem and cup mobilization.
Additional 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
• Common Device Name: 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
• Report Number: 3005180920-2021-00917
• Device Sequence Number: 4472430
• 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: 2008
• Device Explanted Year: 2021
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 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
• Operator of Device: 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
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/28/2021
• Initial Report FDA Received Date: 11/26/2021
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 08/28/2008
• 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: 79 YR
• Patient Sex: Female
• Patient Ethnicity: Non Hispanic
• Patient Race: White