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

Model Number	01.12.022
Health Effect - Clinical Code	Joint Disorder (2373)
Date of Event	06/19/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Batch review performed on 30 june 2020: lot 081456: (b)(4) items manufactured and released on 10-jul-2008.Expiration date: 2013-05-31.No anomalies found related to the problem.To date, (b)(4) items of the same lot have been already sold without any similar reported event since 2016.Visual inspection performed by medacta r&d hip project manager: femoral stem with little amount of residual ha on proximal stem, close to the neck and mild signs of removal on femoral head.It is not possible to determine failure root cause.Clinical evaluation performed by medacta medical affairs director: 12 years after primary cementless tha the stem and head are revised due to mobilization.Extensive radiolucent lines are visible all around the stem, which is radiographically loose.We have no history of the case, so we do not know when instability of the stem started to take place.From the cortical distal thickening it is likely that it started proximally and then progressed, but the reasons for this behaviour remain unknown.There is no mention in the report of investigation for infection.The causes for this long-term loosening cannot be determined.
Event or Problem Description
Revision of a quadra h stem for chronic instability 11 years and 6 months after primary.Also the head has been explanted.It is also reported problem of integration of the primary stem.Painful patient since primary surgery but very resistant to pain.

• Brand Name: QUADRA-H CEMENTLESS, HA COATED STD STEMSIZE 2
• Common Device Name: HIP UNCEMENTED STEM
• Manufacturer (Section D): MEDACTA INTERNATIONAL SA; strada regina; castel san pietro, 6874 ; SZ 6874
• MDR Report Key: 10282341
• Report Number: 3005180920-2020-00423
• Device Sequence Number: 19005161
• Product Code: LZO
• 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: 2020
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 07/16/2020

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: 05/31/2013
• Device Model Number: 01.12.022
• Device Catalogue Number: 01.12.022
• Device Lot Number: 081456
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/03/2020
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/19/2020
• Initial Report FDA Received Date: 07/16/2020
• 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: 68 YR
• Patient Weight: 70