MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA MASTERLOC CEMENTLESS TI COATED STEM SIZE 9 STD; CEMENTLESS FEMORAL STEM

Catalog Number	01.39.009
Health Effect - Clinical Code	Bone Fracture(s) (1870)
Date of Event	06/03/2017
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
On 16 june 2017 the medical affairs performed a clinical evaluation and commented as follows: femoral fracture few days after primary cementless tha.The most probable cause for this event is trauma, although there is no such report.No mention of a postoperative problem, according to report the patient was walking correctly, therefore an intraoperative fracture seems unlikely.No reason to suspect a faulty device.Batch review performed on 04 july 2017.Lot 162118: (b)(4) items manufactured and released on 09 june 2016.Expiration date: 2021-05-23.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.Not available.
Event or Problem Description
X-rays showed a fracture of the greater trochanter.The patient was walking with no pain.The surgeon is unsure how the patient fractured.The surgeon revised the stem and the head.The surgery was completed successfully.X-rays are available.Explants are not available.

• Brand Name: MASTERLOC CEMENTLESS TI COATED STEM SIZE 9 STD
• Common Device Name: CEMENTLESS FEMORAL STEM
• Manufacturer (Section D): MEDACTA INTERNATIONAL SA; strada regina; castel san pietro, 6874 ; SZ 6874
• MDR Report Key: 6685269
• Report Number: 3005180920-2017-00353
• Device Sequence Number: 130300
• Product Code: LZO
• UDI-Device Identifier: 07630030885587
• UDI-Public: 07630030885587
• Combination Product (Y/N): N
• Initial Reporter State: IL
• Initial Reporter Country: US
• PMA/510(K) Number: K151531
• 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): 07/04/2017

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: 05/23/2021
• Device Catalogue Number: 01.39.009
• Device Lot Number: 162118
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/05/2017
• Initial Report FDA Received Date: 07/04/2017
• 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: 87 YR