MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA QUADRA-H CEMENTLESS, HA COATED STD STEM SIZE 4; CEMENTLESS HIP STEM

Catalog Number	01.12.024
Health Effect - Clinical Code	Failure of Implant (1924)
Date of Event	06/21/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Batch review performed on 20 july 2018; lot 176099: (b)(4) items manufactured and released on 18 january 2018.Expiration date: 2023-01-10; 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.
Event or Problem Description
The surgeon templated for a size 4/5 quadra std stem and broached up to a size 4 using a std lateral approach surgical technique.He performed a trial reduction and then double checked the torsional and lineal stability prior to calling for the definitive stem.Upon implantation of the size 4 stem he found it to subside approximately 1 cm.He then removed the stem and broached up to a size 5 and ultimately implanted that stem which sat 3mm deeper than broached.The surgeon felt that it was stable and accepted the position.

• Brand Name: QUADRA-H CEMENTLESS, HA COATED STD STEM SIZE 4
• Common Device Name: CEMENTLESS HIP STEM
• Manufacturer (Section D): MEDACTA INTERNATIONAL SA; strada regina; castel san pietro, switzerland 6874 ; SZ 6874
• MDR Report Key: 7706397
• Report Number: 3005180920-2018-00528
• Device Sequence Number: 732314
• Product Code: JDI
• UDI-Device Identifier: 07630030802058
• UDI-Public: 07630030802058
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• PMA/510(K) Number: K082792
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 07/20/2018

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: 01/10/2023
• Device Catalogue Number: 01.12.024
• Device Lot Number: 176099
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 07/20/2018
• 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: Other
• Patient Age: 61 YR