MAUDE Adverse Event Report: MICROPORT ORTHOPEDICS INC. SLT TAPER COBALT-CHROME FEMORAL HEAD; HIP COMPONENT

Model Number 2601-2602

Device Problem Detachment of Device or Device Component (2907)

Patient Problem No Information (3190)

Event Date 10/28/2018

Event Type  Injury  

Manufacturer Narrative

This complaint will be updated once the investigation is complete.Trends will be evaluated.

Event Description

Allegedly primary surgery was performed on (b)(6) 2017.The surgeon found a dissociation on (b)(6) 2018.The surgeon performed revision surgery on (b)(6) 2018.Only the cup will be returned.

Manufacturer Narrative

This complaint is confirmed.No trends were found.This is a known inherent risk of the device.This issue will continue to be monitored through complaint tracking.- attachment: [18110033-18110034follow-upmemo.Pdf].

Event Description

Allegedly primary surgery was performed on (b)(6) 2017.The surgeon found a dissociation on (b)(6) 2018.The surgeon performed revision surgery on (b)(6) 2018.Only the cup will be returned.

Event Description

Allegedly primary surgery was performed on (b)(6) 2017.The surgeon found a dissociation on (b)(6), 2018.The surgeon performed revision surgery on october 30, 2018.Only the cup will be returned.

Manufacturer Narrative

This complaint is confirmed.No trends were found.This is a known inherent risk of the device.This issue will continue to be monitored through complaint tracking.

• Brand Name: SLT TAPER COBALT-CHROME FEMORAL HEAD
• Type of Device: HIP COMPONENT
• Manufacturer (Section D): MICROPORT ORTHOPEDICS INC.; 5677 airline rd.; arlington TN 38002
• MDR Report Key: 8055519
• MDR Text Key: 126680154
• Report Number: 3010536692-2018-01429
• Device Sequence Number: 1
• Product Code: LZO
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Type of Report: Initial,Followup,Followup
• Report Date: 12/17/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/09/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Other
• Device Model Number: 2601-2602
• Device Catalogue Number: 2601-2602
• Device Lot Number: 1714884
• Was Device Available for Evaluation?: No
• Date Returned to Manufacturer: 11/27/2018
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 11/02/2018
• Date Manufacturer Received: 11/02/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 56 YR