MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA AMISTEM-H PROXIMAL COATING STD STEM SIZE 4; CEMENTLESS FEMORAL STEM

Catalog Number	01.18.174
Health Effect - Clinical Code	Hip Fracture (2349)
Date of Event	11/09/2017
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Clinical evaluation performed on 24 november 2017 by medical affairs: during femoral preparation a fissure in the trochanteric region was observed.Intraoperative femoral fractures are known possible adverse events of total hip replacements, described and quantified in literature.They mainly depend on bone morphology and mechanical properties.In this case, there is no reason to suspect a malfunctioning device.Batch review performed on 05 december 2017.Lot 170859: (b)(4) items manufactured and released on 26 april 2017.Expiration date: 2022-04-11.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
During stem implantation the bone femur was fractured, the fracture was treated with a cerclage.The amistem-h proximal coating was replaced with a cemented stem.
Additional Manufacturer Narrative
Visual inspection performed by r&d product manager on (b)(6) 2018: the implant was analyzed but no evident signs/scratches were noticed on the surfaces.From the analysis of the received piece it was not possible to determine the root cause of the event.
Event or Problem Description
During stem implantation the bone femur was fractured, the fracture was treated with a cerclage.The amistem-h proximal coating was replaced with a cemented stem.

• Brand Name: AMISTEM-H PROXIMAL COATING STD STEM SIZE 4
• Common Device Name: CEMENTLESS FEMORAL STEM
• Manufacturer (Section D): MEDACTA INTERNATIONAL SA; strada regina; castel san pietro, 6874 ; SZ 6874
• MDR Report Key: 7095271
• Report Number: 3005180920-2017-00733
• Device Sequence Number: 19197846
• Product Code: LZO
• UDI-Device Identifier: 07630030804397
• UDI-Public: 07630030804397
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• PMA/510(K) Number: K161635
• 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,Followup
• Report Date (Section B): 02/15/2018

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: 04/11/2022
• Device Catalogue Number: 01.18.174
• Device Lot Number: 170859
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/19/2018
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 11/09/2017
• Supplement Date Received by Manufacturer: 11/09/2017
• Initial Report FDA Received Date: 12/07/2017
• Supplement Report FDA Received Date: 02/15/2018
• 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
• Patient Age: 78 YR