MAUDE Adverse Event Report: MICROPORT ORTHOPEDICS INC. PROFEMUR® NECK VAR/VAL 8DG LONG COBALT CHROME; HIP COMPONENT

Model Number	PHAC1254
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Codes	Pain (1994); Loss of Range of Motion (2032)
Date of Event	10/19/2021
Type of Reportable Event	Serious Injury
Event or Problem Description
Allegedly, patient experienced a sudden onset of pain in the hip joint with subsequent buckling of the leg during normal walking the previous day.Radiological examination revealed a cone fracture.
Additional Manufacturer Narrative
This event will be updated once the investigation is complete.Trends will be evaluated.
Additional Manufacturer Narrative
Due to additional information received from microport orthopedics reliability engineer and further analysis, on section d "suspected medical device" the product listed on initial report as pha04412 femoral head biolox deltaceramic 12/14 - 32 l , lot: 15308521571233 has been corrected and replaced by the product phac1254 profemur® neck var/val 8dg long cobalt chrome , lot no: 0611362523.Also, on section h6 "adverse event problem" the code 1069 has been added for "medical device problem code".

• Brand Name: PROFEMUR® NECK VAR/VAL 8DG LONG COBALT CHROME
• 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: 12957500
• Report Number: 3010536692-2021-00579
• Device Sequence Number: 1792271
• Product Code: LZO
• UDI-Device Identifier: M684PHA044121
• UDI-Public: M684PHA044121
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• PMA/510(K) Number: K130376
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2015
• Device Explanted Year: 2021
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Remedial Action: Recall
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 02/04/2022

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: PHAC1254
• Device Catalogue Number: PHAC1254
• Device Lot Number: 0611362523
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 11/16/2021
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/16/2021
• Supplement Date Received by Manufacturer: 11/16/2021; 11/16/2021
• Initial Report FDA Received Date: 12/07/2021
• Supplement Report FDA Received Date: 12/17/2021; 02/04/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Is the Device Labeled for Single Use? (Y/N): Yes
• If action reported to FDA under 21 USC 360i(g), list FDA-assigned Recall Number or include a statement: Z-2743-2015
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 63 YR
• Patient Sex: Male
• Patient Weight: 85 KG