MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA QUADRA C CEMENTED STEM; FEMORAL CEMENTED STEM

Catalog Number	01.12.043
Health Effect - Clinical Code	No Code Available (3191)
Date of Event	12/04/2017
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Visual inspection of the retrieved instrument, stem impactor code 01.10.10.107 - lot 096178, made on 19 december 2017 by r&d project manager: checking the instrument in the impaction size (half moon), we can suppose that there was an improper use of the instrument.This improper use created deformations to the instrument having it no more usable as indicated in the surgical technique.Visual inspection of the retrieved implant made by r&d project manager on (b)(6) 2017: the stem was analyzed, showing a good surface with some cement attached in the distal part; the half-moon seat for impaction did not show particular deformations.We can probably assume that the stem impactor was used with an improper use.Batch reviews performed on (b)(6) 2018: implant: lot 175332: (b)(4) items manufactured and released on (b)(6) 2017.Expiration date: 2022-09-11.No anomalies found related to the issue.To date, (b)(4) items of the same lot have been already sold without any similar reported event.Instrument: lot 096178: (b)(4) items manufactured and released on (b)(6) 2009.No anomalies found related to the issue; no similar event reported.Additional details received on (b)(6) 2018: semi hard to hard cement had to be removed out of the femur.Femur had to be prepared for the new cemented stem and during this process the surgeon perforated out of the femur, via falsa.Surgeon implanted the new stem in mal positioning, due to bad conditions, but not in via falsa.Maybe it should be removed in a next surgery, but we don't know yet.Femur was not fractured; the event is due to mal preparation of the femur, as per surgeon statement.
Event or Problem Description
During inserting a quadra-c stem, the impactor was jammed with the implant.When removing the impactor, the cemented stem has slipped out of the semi-hardened cement mantle.Residual cement was removed and then another cemented was implanted.

• Brand Name: QUADRA C CEMENTED STEM
• Common Device Name: FEMORAL CEMENTED STEM
• Manufacturer (Section D): MEDACTA INTERNATIONAL SA; strada regina; castel san pietro, 6874 ; SZ 6874
• MDR Report Key: 7163360
• Report Number: 3005180920-2017-00811
• Device Sequence Number: 16158949
• Product Code: LZO
• UDI-Device Identifier: 07630030802249
• UDI-Public: 07630030802249
• Combination Product (Y/N): N
• Initial Reporter Country: SZ
• PMA/510(K) Number: K083558
• 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
• Report Date (Section B): 01/04/2017

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: 09/11/2022
• Device Catalogue Number: 01.12.043
• Device Lot Number: 175332
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/18/2017
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/05/2017
• Initial Report FDA Received Date: 01/04/2018
• 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: Required Intervention