MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA QUADRA-H CEMENTLESS, HA COATED STD STEM SIZE 1, SHORT NECK; CEMENTLESS HIP STEM

Catalog Number	01.12.21SN
Health Effect - Clinical Code	Pain (1994)
Date of Event	01/08/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Batch review performed on 05 february 2019: lot 143801: (b)(4) items manufactured and released on 04-aug-2014.Expiration date: 2019-06-30.No anomalies found related to the problem.To date, all the items of this same lot have been already sold without any similar reported event investigation performed by r&d product manager: based on the picture received, the implant is covered in biological fluids.From preliminary visual investigation, it is not possible to determine an implant-related failure root cause.Clinical evaluation performed by medical affairs manager: hip revision surgery occurred 4 years after cementless total hip arthroplasty in a (b)(6) woman.In the radiographic image provided, radiolucent lines in gruen zones 1 and 7 are visible.No information on general health status of the patient is available.Aseptic loosening is a possible literature described adverse event after cementless hip replacements and causes are often unknown.The reason of this failure cannot be determined.
Event or Problem Description
Revision surgery performed, 4 years and 2 months after primary surgery, due to pain and stem loosening.The surgeon revised the implant with a cemented stem.

• Brand Name: QUADRA-H CEMENTLESS, HA COATED STD STEM SIZE 1, SHORT NECK
• Common Device Name: CEMENTLESS HIP STEM
• Manufacturer (Section D): MEDACTA INTERNATIONAL SA; strada regina; castel san pietro, switzerland 6874 ; SZ 6874
• MDR Report Key: 8310177
• Report Number: 3005180920-2019-00027
• Device Sequence Number: 1697380
• Product Code: JDI
• UDI-Device Identifier: 07630030802614
• UDI-Public: 07630030802614
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• 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): 02/06/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 06/30/2019
• Device Catalogue Number: 01.12.21SN
• Device Lot Number: 143801
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/07/2019
• Initial Report FDA Received Date: 02/06/2019
• 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: 66 YR