MAUDE Adverse Event Report: MICROPORT ORTHOPEDICS INC. PROCOTYL® PRIME E-CLASS XLPE LIPPED LINER 32 MM G; HIP COMPONENT

Model Number P3LELB32

Device Problems Detachment of Device or Device Component (2907); Noise, Audible (3273)

Patient Problem No Information (3190)

Event Date 06/21/2019

Event Type  Injury  

Manufacturer Narrative

This event will be updated when investigation is complete.

Event Description

Allegedly primary surgery was performed on (b)(6) 2019.Two weeks after the operation, the patient pointed out that "the rattle noise occurs in the body", and the sound disappeared a few days later, but when ct was taken, the 32 mm head was acetabular.Because it was at a position offset from the lid cup, it is presumed that the polyethylene liner was likely to be dislocated, and day 21 poly liner removal + replacement surgery was performed.

Event Description

Allegedly primary surgery was performed on (b)(6) 2019.Two weeks after the operation, the patient pointed out that "the rattle noise occurs in the body", and the sound disappeared a few days later, but when ct was taken, the 32 mm head was acetabular.Because it was at a position offset from the lid cup, it is presumed that the polyethylene liner was likely to be dislocated, and day 21 poly liner removal + replacement surgery was performed.

• Brand Name: PROCOTYL® PRIME E-CLASS XLPE LIPPED LINER 32 MM G
• Type of Device: HIP COMPONENT
• Manufacturer (Section D): MICROPORT ORTHOPEDICS INC.; 5677 airline rd.; arlington TN 38002
• MDR Report Key: 8796033
• MDR Text Key: 151221279
• Report Number: 3010536692-2019-00904
• Device Sequence Number: 1
• Product Code: LZO
• UDI-Device Identifier: M684P3LELB321
• UDI-Public: M684P3LELB321
• Combination Product (y/n): N
• PMA/PMN Number: K171181
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Type of Report: Initial,Followup
• Report Date: 02/11/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/16/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Other
• Device Model Number: P3LELB32
• Device Catalogue Number: P3LELB32
• Device Lot Number: 1750164
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/16/2019
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 06/25/2019
• Date Manufacturer Received: 06/25/2019
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 75 YR