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

Model Number PHA04414

Device Problem Patient-Device Incompatibility (2682)

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 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.

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
• 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: 14348509
• MDR Text Key: 291326519
• Report Number: 3010536692-2022-00162
• Device Sequence Number: 1
• Product Code: LZO
• UDI-Device Identifier: M684PHA044141
• UDI-Public: M684PHA044141
• Combination Product (y/n): N
• Reporter Country Code: UK
• PMA/PMN Number: K130376
• 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,Followup
• Report Date: 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
• Device Operator: 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
• Initial Date Manufacturer Received: 04/22/2022
• Initial Date FDA Received: 05/10/2022
• Supplement Dates Manufacturer Received: 04/22/2022
• Supplement Dates FDA Received: 08/26/2022
• 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