MAUDE Adverse Event Report: MicroPort Orthopedics Inc. PROFEMUR® NECK NEUTRAL SHORT COBALT CHROME; Hip Component

Model Number	PHAC1202
Medical Device Problem Code	Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	Pain (1994)
Type of Reportable Event	Serious Injury

• Brand Name: PROFEMUR® NECK NEUTRAL SHORT 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: 50923576
• Report Number: 3010536692-2026-00471
• Device Sequence Number: 5803971
• Product Code: LZO
• UDI-Device Identifier: 00192629087255
• UDI-Public: 00192629087255
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K091423
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2013
• Device Explanted Year: 2026
• Reporter Type: Manufacturer
• Report Source: Distributor
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 09/28/2026

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 Expiration Date: 06/17/2021
• Device Model Number: PHAC1202
• Device Catalogue Number: PHAC1202
• Device Lot Number: 1503093
• 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: 09/03/2026
• Initial Report FDA Received Date: 09/28/2026
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 06/12/2013
• Is the Device Labeled for Single Use? (Y/N): Yes
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 76 YR
• Patient Sex: Female