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

Model Number 2601-2801

Device Problem Disassembly (1168)

Patient Problem Pain (1994)

Event Type  Injury  

Manufacturer Narrative

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

Event Description

Allegedly the surgeon performed bha surgery on (b)(6).The patient felt a pain in her hip and the surgeon found a stem rotation and a dissociation of the cup and head on (b)(6).The surgeon performed tha surgery on (b)(6).

• 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
• Manufacturer (Section G): MICROPORT ORTHOPEDICS INC.; 5677 airline rd.; arlington TN 38002
• Manufacturer Contact: 5677 airline road; arlington, TN 38002 ; 9018674771
• MDR Report Key: 7660526
• MDR Text Key: 113086064
• Report Number: 3010536692-2018-00892
• 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
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 07/03/2018

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: Other
• Device Model Number: 2601-2801
• Device Catalogue Number: 2601-2801
• Device Lot Number: 1719850
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 06/20/2018
• Initial Date Manufacturer Received: 06/20/2018
• Initial Date FDA Received: 07/03/2018
• Supplement Dates Manufacturer Received: 06/20/2018
• Supplement Dates FDA Received: 12/27/2018
• 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
• Patient Age: 86 YR
• Patient Weight: 35