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

Model Number	PHA04416
Health Effect - Clinical Code	Metal Related Pathology (4530)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
This event will be updated once the investigation is complete.Trends will be evaluated.
Event or Problem 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
• Common Device Name: 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
• Report Number: 3010536692-2022-00347
• Device Sequence Number: 11226559
• Product Code: LZO
• UDI-Device Identifier: M684PHA044161
• UDI-Public: M684PHA044161
• Combination Product (Y/N): N
• Initial Reporter Country: SP
• PMA/510(K) Number: K130376
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2015
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Distributor
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 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
• Operator of Device: 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
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/05/2022
• Supplement Date Received by Manufacturer: 09/05/2022
• Initial Report FDA Received Date: 09/26/2022
• Supplement Report FDA Received Date: 11/10/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Is the Device Labeled for Single Use? (Y/N): Yes
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown