MAUDE Adverse Event Report: MICROPORT ORTHOPEDICS INC. CONSERVE® BFH® HEAD 46MM MEDIUM NECK; HIP COMPONENT

Model Number 38014600

Device Problem Device Dislodged or Dislocated (2923)

Patient Problem Metal Related Pathology (4530)

Event Type  Injury  

Event Description

Allegedly, loosening ? stem|lysis ? stem|peri-prosthetic fracture ? stem|dislocation/subluxation|adverse soft tissue reaction to particulate.Debris.Side: r.Revision njr: (b)(4).Gender: m.Explanted: femoral stem, acetabular cup (not mpo components).

Manufacturer Narrative

See attached.

• Brand Name: CONSERVE® BFH® HEAD 46MM MEDIUM NECK
• 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: 18940274
• MDR Text Key: 338126381
• Report Number: 3010536692-2024-00087
• Device Sequence Number: 1
• Product Code: KWA
• UDI-Device Identifier: M684380146001
• UDI-Public: M684380146001
• Combination Product (y/n): N
• Reporter Country Code: UK
• PMA/PMN Number: K021349
• 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: 02/21/2024

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: 38014600
• Device Catalogue Number: 38014600
• Device Lot Number: 95275580
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 02/02/2024
• Initial Date FDA Received: 03/20/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 72 YR
• Patient Sex: Male
• Patient Weight: 82 KG