MAUDE Adverse Event Report: MICROPORT ORTHOPEDICS INC. PROFEMUR® NECK A/R 15DG SHORT COBALT CHROME; HIP COMPONENT

Model Number	PHAC1242
Medical Device Problem Codes	Break (1069); Corroded (1131); Material Frayed (1262)
Health Effect - Clinical Codes	Neuropathy (1983); Pain (1994)
Type of Reportable Event	Serious Injury
Event or Problem Description
Allegedly, on (b)(6) 2012, patient had a wright medical artificial hip implanted in the right side of his body in a procedure known as a total hip arthroplasty {tha).Patient's (b)(6) 2012, hip implant surgery was performed at the hospital (b)(6).After his initial recovery from the (b)(6) 2012, hip surgery, for several years patient's wright medical artificial hip performed as expected, and the pain and disability patient had experienced in his right hip prior to his (b)(6) 2012, hip replacement surgery had been substantially relieved.Late in the year 2019 patient developed adverse symptoms including, but not limited to, progressively worsening pain in and around his right hip joint.Patient's orthopedic surgeon, subsequently, in the year 2021, informed patient that in his medical judgment it was advisable to undergo a right hip revision surgery to remove the profemur® hip system, including the profemur® plus cocr modular neck and the profemur® tl femoral stem, and replace it with a hip stem system of a different medical device manufacturer, zimmer-biomet.Surgeon also informed patient that it would be medically necessary to remove and replace the conserve® femoral head.On (b)(6) 2020, patient had a revision surgery performed on his right hip.Due to micromotion and fretting corrosion of the oblong taper of the profemur® plus cocr modular neck where it seated in the pocket of the stem, the profemur® plus cocr modular neck implanted in patient?s right hip corroded, causing physical injury to patient.Patient sustained injuries and damages including, but not limited to, pain, suffering, disability, and physical impairment, as well as neurologic symptoms including peripheral neuropathy, tinnitus, balance/coordination issues, a heal fracture as a direct result of those balance/coordination issues, and b 12 deficiency.It is also indicated that patient's profemur® plus cocr modular neck had micromotion, fretting corrosion, galvanic corrosion, and fracture.It is not indicated whether the shell and liner components were revised or left in place.
Additional Manufacturer Narrative
This event will be updated once the investigation is complete.Trends will be evaluated.

• Brand Name: PROFEMUR® NECK A/R 15DG SHORT 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: 15331779
• Report Number: 3010536692-2022-00307
• Device Sequence Number: 15074449
• Product Code: JDL
• UDI-Device Identifier: M684PHAC12421
• UDI-Public: M684PHAC12421
• Combination Product (Y/N): N
• Initial Reporter State: NY
• Initial Reporter Country: US
• PMA/510(K) Number: K091423
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2012
• Device Explanted Year: 2020
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Other
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 10/21/2022

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: PHAC1242
• Device Catalogue Number: PHAC1242
• Device Lot Number: 0701180827
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 08/12/2022
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/12/2022
• Supplement Date Received by Manufacturer: 08/12/2022
• Initial Report FDA Received Date: 08/31/2022
• Supplement Report FDA Received Date: 10/21/2022
• 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 Sex: Unknown