MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA QUADRA-H CEMENTLESS, HA COATED STD STEMS SIZE 6, SHORT NECK; UNCEMENTED HIP STEM

Model Number	01.12.26SN
Health Effect - Clinical Code	Bone Fracture(s) (1870)
Date of Event	12/21/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Batch review performed on 27 december 2019: lot 150206: (b)(4) items manufactured and released on 12-may-2015.Expiration date: 2020-03-31.No anomalies found related to the problem.To date, (b)(4) items of the same lot have been already sold without any other similar reported event.
Event or Problem Description
The patient had a primary hip surgery on (b)(6) 2015.Subsequently, the patient came in reporting pain due to a fractured femur.The cause of the fracture was unknown.The surgeon cabled and plated the fracture and surgery was completed successfully.Presently, on (b)(6) 2019 (3 months and a half after primary) the patient came in complaining of instability due to a subsided stem with nonunion.The cause of the subsided stem is unknown.The surgeon revised the stem, head, and liner and the surgery was completed successfully.

• Brand Name: QUADRA-H CEMENTLESS, HA COATED STD STEMS SIZE 6, SHORT NECK
• Common Device Name: UNCEMENTED HIP STEM
• Manufacturer (Section D): MEDACTA INTERNATIONAL SA; strada regina; castel san pietro, 6874 ; SZ 6874
• MDR Report Key: 9605407
• Report Number: 3005180920-2019-01124
• Device Sequence Number: 546801
• Product Code: LZO
• UDI-Device Identifier: 07630030802669
• UDI-Public: 07630030802669
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K093944
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2015
• Device Explanted Year: 2019
• Reporter Type: Manufacturer
• Report Source: other
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 01/20/2020

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: 03/31/2020
• Device Model Number: 01.12.26SN
• Device Catalogue Number: 01.12.26SN
• Device Lot Number: 150206
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/23/2020
• Initial Report FDA Received Date: 01/20/2020
• 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