MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA VERSAFITCUP ACETABULAR SHELL Ø 56; CEMENTLESS ACETABULAR SHELL

Catalog Number 01.26.56MB

Device Problem Fracture (1260)

Patient Problem Bone Fracture(s) (1870)

Event Date 05/17/2017

Event Type  Injury  

Manufacturer Narrative

Additional information received on (b)(6) 2017 and includes: the patient had some type of syndrome that caused the anatomy to not be normal.On (b)(6) 2017 the medical affairs director performed a clinical evaluation and commented as follows: intraoperative acetabular 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, according to the report, the acteabular component was well fixed and didn't require any additional procedure.There is no reason to suspect a malfunctioning device.Batch review performed on (b)(6) 2017.Lot 161584: 69 items manufactured and released on (b)(6) 2016.Expiration date: 2021-06-02.No anomalies found related to the problem.To date, 46 items of the same lot have been already sold without any similar reported event.The cup was left in place, not explanted.

Event Description

After impaction of the cup, the surgeon noticed the acetabular wall had fractured.The cup was well fixed.No additional implants needed, no revision is required.The surgery was completed successfully.

• Brand Name: VERSAFITCUP ACETABULAR SHELL Ø 56
• Type of Device: CEMENTLESS ACETABULAR SHELL
• Manufacturer (Section D): MEDACTA INTERNATIONAL SA; strada regina; castel san pietro, 6874 ; SZ 6874
• Manufacturer (Section G): MEDACTA INTERNATIONAL SA; strada regina; castel san pietro, 6874 ; SZ 6874
• Manufacturer Contact: stefano baj ; strada regina; castel san pietro, 6874 ; SZ 6874
• MDR Report Key: 6646021
• MDR Text Key: 77704179
• Report Number: 3005180920-2017-00315
• Device Sequence Number: 1
• Product Code: MEH
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K083116
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 06/16/2017

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
• Device Operator: Health Professional
• Device Expiration Date: 06/02/2021
• Device Catalogue Number: 01.26.56MB
• Device Lot Number: 161584
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 05/17/2017
• Initial Date FDA Received: 06/16/2017
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 06/14/2016
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 60 YR