MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA STEM: QUADRA-H CEMENTLESS, HA COATED LAT STEM SIZE 6; CEMENTLESS STEM

Model Number	01.12.036
Health Effect - Clinical Code	Inadequate Osseointegration (2646)
Date of Event	11/04/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Batch review performed on 11 november 2021.Lot 04-1683: (b)(4) items manufactured and released on 25-feb-2005.Expiration date: 2009-11-30.No anomalies found related to the problem.To date, all items of the same lot have been already sold without any similar reported event since 2017.Clinical evaluation performed by medical affairs director: 15 years after primary cementless tha, a trauma causes pelvic fracture and consequent mobilization of the acetabular cup.During revision surgery, the stem is deemed loose too and replaced.No reason to suspect a faulty device as the root cause for this adverse event.Additional item involved in the event, batch review performed on 11 november 2021: cup: versafitcup cc 01.26.50mbt acetabular shell cc ø 50 lot.060775 (the item is not registered in usa).Lot 060775: (b)(4) items manufactured and released on 10-jul-2006.Expiration date: 2011-may-31.No anomalies found related to the problem.To date, all items of the same lot have been already sold without any similar reported event since 2017.
Event or Problem Description
The loosening of the cup was noticed in a control x-ray, the loosening of the stem was noticed during surgery.Loosening was maybe due to a trauma of the patient.Revision surgery was performed 15 years and 2 months after primary, all implants were replaced.

• Brand Name: STEM: QUADRA-H CEMENTLESS, HA COATED LAT STEM SIZE 6
• Common Device Name: CEMENTLESS 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: 12891360
• Report Number: 3005180920-2021-00943
• Device Sequence Number: 4571975
• Product Code: LZO
• UDI-Device Identifier: 07630030802188
• UDI-Public: 07630030802188
• 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: 2006
• 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): 11/30/2021

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: 11/30/2009
• Device Model Number: 01.12.036
• Device Catalogue Number: 01.12.036
• Device Lot Number: 04-1683
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/04/2021
• Initial Report FDA Received Date: 11/30/2021
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 02/25/2005
• 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: 81 YR
• Patient Sex: Male
• Patient Weight: 56 KG
• Patient Race: White