MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA QUADRA H CEMENTLESS STEM; CEMENTLESS FEMORAL STEM SIZE 2 STD SHORT NECK

Catalog Number	01.12.22SN
Health Effect - Clinical Code	Bone Fracture(s) (1870)
Date of Event	07/12/2017
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
On 27 july 2017 the medical affairs made the following analysis: postoperative femoral fracture occurred 1 month after primary cementless tha.Femoral fractures are a possible, literature described adverse event after tha.They may be due to the normal intraoperative bone weakening caused by the femoral preparation.No reason in this case to suspect a defective implant.Batch review performed on 31 july 2017: lot 132364: (b)(4) items manufactured and released on 02 august 2013.Expiration date: 2018-06-30.No anomalies found related to the reported issue.To date, (b)(4) items of the same lot have been already sold without any similar reported event.
Event or Problem Description
Revision surgery 1 month after primary due to bone fracture and stem subsidence.The revision surgery was completed successfully.
Additional Manufacturer Narrative
On (b)(6) 2017 the (b)(4) project manager performed a visual inspection of the retrieved items and commented as follows.The stem showed a coating totally present in the entire body, due to the short time of the implant in the patient.Fibrotic tissue was noticed inside some macrostructures and the neck had some signs on the inferior part, probably occurred during extraction.The ceramic ball head showed some signs on the rim and one on the surface due to removal.From the received parts it is not possible to determine the root cause of the event.

• Brand Name: QUADRA H CEMENTLESS STEM
• Common Device Name: CEMENTLESS FEMORAL STEM SIZE 2 STD SHORT NECK
• Manufacturer (Section D): MEDACTA INTERNATIONAL SA; strada regina; castel san pietro, 6874 ; SZ 6874
• MDR Report Key: 6763328
• Report Number: 3005180920-2017-00442
• Device Sequence Number: 1967571
• Product Code: JDI
• UDI-Device Identifier: 07630030802621
• UDI-Public: 07630030802621
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• PMA/510(K) Number: K082792
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2017
• Device Explanted Year: 2017
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 10/20/2017

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: 06/30/2018
• Device Catalogue Number: 01.12.22SN
• Device Lot Number: 132364
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/21/2017
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 07/12/2017
• Supplement Date Received by Manufacturer: 07/12/2017
• Initial Report FDA Received Date: 08/03/2017
• Supplement Report FDA Received Date: 10/20/2017
• 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: 61 YR