MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA MINIMAX CEMENTLESS ANATOMICAL STEM SIZE 6 LEFT

Catalog Number	01.13.106L
Health Effect - Clinical Code	Bone Fracture(s) (1870)
Date of Event	10/11/2017
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Batch review performed on 09 november 2017.(b)(4).
Event or Problem Description
Revision surgery was necessary 21 days after primary.The stem was loose and it was found that there was a bone fracture.No trauma reported.

• Brand Name: MINIMAX CEMENTLESS ANATOMICAL STEM SIZE 6 LEFT
• Common Device Name: CEMENTLESS ANATOMICAL STEM
• Manufacturer (Section D): MEDACTA INTERNATIONAL SA; strada regina; castel san pietro, 6874 ; SZ 6874
• MDR Report Key: 7018029
• Report Number: 3005180920-2017-00648
• Device Sequence Number: 940071
• Product Code: LZO
• UDI-Device Identifier: 07630030803253
• UDI-Public: 07630030803253
• Combination Product (Y/N): N
• Initial Reporter Country: IT
• PMA/510(K) Number: K170845
• 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): 11/10/2017

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: 11/23/2020
• Device Catalogue Number: 01.13.106L
• Device Lot Number: 154284
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 10/11/2017
• Initial Report FDA Received Date: 11/10/2017
• 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: 70 YR
• Patient Weight: 100