MAUDE Adverse Event Report: MICROPORT ORTHOPEDICS INC. ACETABULAR CUP; HIP COMPONENT

Model Number PHA06210

Device Problem Difficult to Insert (1316)

Patient Problem No Information (3190)

Event Date 05/13/2019

Event Type  Injury  

Manufacturer Narrative

The complaint will be updated once the investigation is completed.Trends will be evaluated.

Event Description

Allegedly, once again for this customer both pe inlays (­­0° and 15°) of group d could be fixed into implanted shell size 50.The application was done professionally with closure of the screw in the metal back, cleaning of the metal back and exposure of all soft tissues.In addition, the shell has to be solved after several attempts to fix the inlay, so that a further reaming of the bone was required to anchor another press fit-shell size 52.Due to the previous incidents, the screw plug was omitted when repeatedly inserting the 52 cup shell and the inlay could be fixed immediately.It is expressly pointed out that the screw plug was correctly lowered; there is no application error.Due to this incident, the surgery time was extended by 45 minutes; in addition, the customer still wanted to consider switching to depuy pinnacle shell.

• Brand Name: ACETABULAR CUP
• Type of Device: HIP COMPONENT
• Manufacturer (Section D): MICROPORT ORTHOPEDICS INC.; 5677 airline rd.; arlington TN 38002
• Manufacturer (Section G): MICROPORT ORTHOPEDICS INC.; 5677 airline rd.; arlington TN 38002
• Manufacturer Contact: 5677 airline road; arlington, TN 38002 ; 9018674771
• MDR Report Key: 8645545
• MDR Text Key: 146220197
• Report Number: 3010536692-2019-00753
• Device Sequence Number: 1
• Product Code: HWT
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 04/23/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/28/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Other
• Device Model Number: PHA06210
• Device Catalogue Number: PHA06210
• Device Lot Number: 1780306
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 05/14/2019
• Date Manufacturer Received: 05/14/2019
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention