MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA QUADRA-H CEMENTLESS, HA COATED STD STEM SIZE 0, SHORT NECK; CEMENTLESS HIP STEM

Catalog Number	01.12.20SN
Health Effect - Clinical Code	Bone Fracture(s) (1870)
Date of Event	12/14/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Batch review performed on 10 january 2019.Lot 181777: (b)(4) items manufactured and released on 11 july 2018.Expiration date: 2023-06-26.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.Preliminary investigation performed by r&d product manager on december 18, 2018.Preliminary investigation shows stem and ceramic head covered in biological fluids.It is not possible to determine failure root cause.Clinical evaluation performed by medical affairs director on january 04, 2019 partial hip revision surgery (stem and head) occurred 2 weeks after primary cementless total hip arthroplasty in a (b)(6) year old woman due to periprosthetic fracture.Immediate postoperative radiographic image shows a slightly varus undersized stem, probably subsided after two weeks but we cannot determine whether the subsidence took place before or after the fracture.The reason of this choice cannot be determined on the basis of a single projection postoperative x-ray.There is no reason to suspect a faulty device.
Event or Problem Description
About 24 days after surgery for a bone fracture due to undersized stem, the surgeon revised the patient joint swapping successfully the stem and the head.

• Brand Name: QUADRA-H CEMENTLESS, HA COATED STD STEM SIZE 0, 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: 8235434
• Report Number: 3005180920-2018-01087
• Device Sequence Number: 19192385
• Product Code: JDI
• UDI-Device Identifier: 07630030802607
• UDI-Public: 07630030802607
• 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: 2018
• Device Explanted Year: 2018
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 01/10/2019

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: 06/26/2023
• Device Catalogue Number: 01.12.20SN
• Device Lot Number: 181777
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/14/2018
• Initial Report FDA Received Date: 01/10/2019
• 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: 62 YR
• Patient Weight: 75