MAUDE Adverse Event Report: MICROPORT ORTHOPEDICS INC. FEMORAL HEAD BIOLOX DELTA CERAMIC 12/14 - 36 M; HIP COMPONENT

Model Number PHA04416

Device Problems Patient-Device Incompatibility (2682); Device Dislodged or Dislocated (2923)

Patient Problem Metal Related Pathology (4530)

Event Type  Injury  

Manufacturer Narrative

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

Event Description

Allegedly, patient received a left hip prosthesis on (b)(6) 2015 and a right hip prosthesis on (b)(6) 2016, both were performed at hospital (b)(6).During 2017, patient suffered his first hip dislocation.Then, during 2018, patient suffered a second dislocation.On the same year, 2018, the patient was diagnosed with a pseudotumor.Patient suffered an adverse reaction to the metal coming from the implanted devices.It is to note that patient is allergic to cobalt and that the prosthesis remains implanted in patient.Reporter stated on initial email notification that this was a case implanted in 2015 with confirmed metallosis in posterior analysis.

• Brand Name: FEMORAL HEAD BIOLOX DELTA CERAMIC 12/14 - 36 M
• 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: 15487371
• MDR Text Key: 300634465
• Report Number: 3010536692-2022-00347
• Device Sequence Number: 1
• Product Code: LZO
• UDI-Device Identifier: M684PHA044161
• UDI-Public: M684PHA044161
• Combination Product (y/n): N
• Reporter Country Code: SP
• PMA/PMN Number: K130376
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Distributor
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 11/10/2022

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: PHA04416
• Device Catalogue Number: PHA04416
• Device Lot Number: 1608539
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 09/05/2022
• Initial Date Manufacturer Received: 09/05/2022
• Initial Date FDA Received: 09/26/2022
• Supplement Dates Manufacturer Received: 09/05/2022
• Supplement Dates FDA Received: 11/10/2022
• 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