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

Model Number	PHA04414
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 was revised due to adverse soft tissue reaction to particulate debris components not revised: product:profemur® l hip stem size 5 ha coated product id: pha05510, lot#: 1674917, qty:1.Product:profemur® neck a/r 8dglong cobalt chrome product id: phac1234, lot#: 1830376.Qty:1 revision njr number: (b)(4).Side: l.Primary asa: p2 mild disease not incapacitating.
Additional Manufacturer Narrative
Due to additional information received regarding this event, this manufacturer report 22040167 it's considered no longer reportable since there is no alleged deficiency and no direct complaint stated against the main device of this report(pha04414 biolox delta ceramic head 36mm -4mm neck).Please void this report.

• Brand Name: FEMORAL HEAD BIOLOX DELTA CERAMIC 12/14 - 36 S
• 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: 14348509
• Report Number: 3010536692-2022-00162
• Device Sequence Number: 19858261
• Product Code: LZO
• UDI-Device Identifier: M684PHA044141
• UDI-Public: M684PHA044141
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• PMA/510(K) Number: K130376
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2022
• Device Explanted Year: 2022
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 08/26/2022

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: PHA04414
• Device Catalogue Number: PHA04414
• Device Lot Number: 1836016
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 04/22/2022
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/22/2022
• Supplement Date Received by Manufacturer: 04/22/2022
• Initial Report FDA Received Date: 05/10/2022
• Supplement Report FDA Received Date: 08/26/2022
• 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