MAUDE Adverse Event Report: MicroPort Orthopedics Inc. PROFEMUR® NECK A/R 8DG LONG COBALT CHROME; Hip Component

Model Number	PHAC1234
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	Insufficient Information (4580)
Type of Reportable Event	Serious Injury
Event or Problem Description
Allegedly, patient was revised due to implant fracture of a nonceramic component - stem.Srnjr number: (b)(6).Side: l.Gender: m.Non revised mpo products: product id: pha06264 procotyl l acetabular cup beaded coated + ha 54 group e/ lot no.: 1530805/ qty: 1.Product id: pha04510 rimlock biolox delta ceramic liner 36 group e/ lot no.: 1476911/ qty: 1.
Additional Manufacturer Narrative
Microport was made aware of this revision from the united kingdom national joint registry.Reference investigation memorandum for full information.The indications for revision are known inherent risks of the device and/or procedure.Furthermore, there were no increases in hazard and harm risk levels identified for these product families.Therefore, no additional action is required.

• Brand Name: PROFEMUR® NECK A/R 8DG LONG COBALT CHROME
• Common Device Name: Hip Component
• Manufacturer (Section D): MicroPort Orthopedics Inc.; 5677 airline rd.; arlington TN 38002
• Manufacturer Contact: rachael wise ; 5677 airline road; arlington, TN 38002 ; +1(901)867-4771
• MDR Report Key: 50048377
• Report Number: 3010536692-2026-00321
• Device Sequence Number: 15823024
• Product Code: JDL
• UDI-Device Identifier: 00192629087323
• UDI-Public: 00192629087323
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• PMA/510(K) Number: K091423
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2014
• Device Explanted Year: 2025
• Reporter Type: Manufacturer
• Report Source: Foreign
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 07/27/2026

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: PHAC1234
• Device Catalogue Number: PHAC1234
• Device Lot Number: 0711378937
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/29/2026
• Initial Report FDA Received Date: 07/28/2026
• 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 Age: 38 YR
• Patient Sex: Male