MAUDE Adverse Event Report: MICROPORT ORTHOPEDICS INC. UNKNOW HIP RESURFACING SYSTEM; HIP COMPONENT

Model Number 38XXXXXX

Device Problem Break (1069)

Patient Problem Insufficient Information (4580)

Event Type  Injury  

Event Description

Allegedly, two studies were received that were carried out in los angeles, california, one in 2008 (eleven years of experience with metal-on-metal hybrid hip resurfacing) and another in 2018 (the mean ten-year results of metal-on-metal hybrid hip resurfacing arthroplasty).These studies were based on data collected from 1996 to 2006 and from 1996 to 2012.From these data 1074 patients were involved, of which 103 revision surgeries were performed (11 neck fractures, 26 femoral loosening, 4 sepsis, 15 wear, 25 acetabular loosening, 2 instability, 1 tissue reaction, 1 osteolysis, 1 pain, 3 unknown reasons, 1 poor bone quality, 2 dislocation and 1 subluxation).This incident is capturing a neck fracture revision.

Manufacturer Narrative

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

Manufacturer Narrative

See attached.

• Brand Name: UNKNOW HIP RESURFACING SYSTEM
• Type of Device: HIP COMPONENT
• Manufacturer (Section D): MICROPORT ORTHOPEDICS INC.; 5677 airline rd.; arlington TN 38002
• Manufacturer Contact: rachael wise ; 5677 airline road; arlington, TN 38002 ; 9018674771
• MDR Report Key: 18962010
• MDR Text Key: 338432213
• Report Number: 3010536692-2024-00146
• Device Sequence Number: 1
• Product Code: LZO
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 03/22/2024

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 Model Number: 38XXXXXX
• Device Catalogue Number: 38XXXXXX
• Device Lot Number: N/I
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 03/04/2024
• Initial Date FDA Received: 03/22/2024
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: Yes
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention