MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA AMISTEM C - CEMENTED STEM SIZE 6 STD; CEMENTED FEMORAL STEM

Catalog Number	01.18.156
Health Effect - Clinical Code	Bone Fracture(s) (1870)
Date of Event	08/30/2017
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Batch reviews performed on 25 september 2017.Lot 147997: (b)(4) items manufactured and released on 11 february 2015.Expiration date: 2019-12-31.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.Mpact acetabular shell ø56 two-holes, code 01.32.156dh, lot.160478 (k132879) (b)(4) items manufactured and released on 31 may 2016.Expiration date: 2021-05-17.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 surgery, greater trochanter and femoral bone were fractured.Greater trochanter fracture was confirmed after extending the femur.Femoral bone fracture (below the stem) was confirmed after implantation of the stem.Due to this event, the surgery was prolonged about 4 hours.It was not clear, but greater trochanter fracture might be occured during external rotation after femoral head resection.Femoral bone fracture might be occured while rasping or inserting the stem.

• Brand Name: AMISTEM C - CEMENTED STEM SIZE 6 STD
• Common Device Name: CEMENTED FEMORAL STEM
• Manufacturer (Section D): MEDACTA INTERNATIONAL SA; strada regina; castel san pietro, 6874 ; SZ 6874
• MDR Report Key: 6903980
• Report Number: 3005180920-2017-00543
• Device Sequence Number: 1443983
• Product Code: LZO
• UDI-Device Identifier: 07630030804311
• UDI-Public: 07630030804311
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K103189
• 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
• Report Date (Section B): 09/29/2017

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: 12/31/2019
• Device Catalogue Number: 01.18.156
• Device Lot Number: 147997
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 08/30/2017
• Initial Report FDA Received Date: 09/29/2017
• 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: Other
• Patient Age: 68 YR
• Patient Weight: 56