MAUDE Adverse Event Report: MICROPORT ORTHOPEDICS INC. FEMORAL HEAD BIOLOX DELTA CERAMIC 12/14 -40 S; HIP COMPONENT

Model Number	PHA04420
Health Effect - Clinical Code	Unspecified Infection (1930)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The alleged complaint could not be confirmed.These ceramic components were revised approximately 2-3 weeks after the primary operation due to infection.The revised products were not returned for investigation.No operative notes or other clinically relevant documentation has been provided to confirm this complaint.Review of the device history record for this lot indicates that this product met all acceptance criteria at the time of manufacturing.Infection is a known risk of any surgical procedure.The source of the infection cannot be determined from the available information.The microport hip systems package insert (150803-8) lists "delayed wound healing; deep wound infection (early or late) which may necessitate removal of the prosthesis.On rare occasions, arthrodesis of the involved joint or amputation of the limb may be required" as potential adverse effects of total hip arthroplasty (tha).There were no trends identified per mpo trending procedures.This issue will continue to be monitored through complaint tracking.
Event or Problem Description
Allegedly, patient was revised due to infection.Revision njr number: (b)(4).Side:r; primary asa: p2 - mild disease not incapacitating.Components not revised: procotyl l beaded and ha coated cup size 56mm / product id: pha06266 / lot no.: 1851198.Profemur tl classic fixed neck size 6 / product id: prtls026 / lot no.: 1832007.

• Brand Name: FEMORAL HEAD BIOLOX DELTA CERAMIC 12/14 -40 S
• Common Device Name: HIP COMPONENT
• Manufacturer (Section D): MICROPORT ORTHOPEDICS INC.; 5677 airline rd.; arlington TN 38002
• MDR Report Key: 12127883
• Report Number: 3010536692-2021-00362
• Device Sequence Number: 4765477
• Product Code: MRA
• UDI-Device Identifier: M684PHA044201
• UDI-Public: M684PHA044201
• 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: 2021
• Device Explanted Year: 2021
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 07/07/2021

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: Health Professional
• Device Model Number: PHA04420
• Device Catalogue Number: PHA04420
• Device Lot Number: 1815691
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 06/17/2021
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/17/2021
• Initial Report FDA Received Date: 07/07/2021
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention