MAUDE Adverse Event Report: MICROPORT ORTHOPEDICS INC. CONSERVE® TOTAL A-CLASS® 40MM FEMORAL HEAD; HIP COMPONENT

Model Number 38AC4000

Device Problem Device Dislodged or Dislocated (2923)

Patient Problem Pain (1994)

Event Type  Injury  

Event Description

Allegedly, on (b)(6) 2012, patient had a wright medical artificial hip implanted in the right side of his body.On or about (b)(6) 2020 patient was told that he suffered a broken screw holding the dynasty cup, leading to loosening of the cup and pain in his right hip, and that it was advisable that he undergo surgery to remove the dynasty cup and screws and replace and refix the cup and fixation screws (it is not indicated which screw was broken since patient had 3 screws implanted.Also, it has not been indicated which cup and screws were used to replace the dynasty cup and screws).This event is captured under microport orthopedics incident group number: (b)(4).On or about (b)(6) 2022, patient suffered a right hip implant dislocation.By (b)(6) 2022, patient developed symptoms of, among others, low back pain, development of a cyst on his right thigh, in addition to suffering recent right hip dislocation.Patient's orthopedic surgeon after the (b)(6) 2022 dislocation, 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 stem, and replace it with a hip stem system of a different medical device manufacturer, smith & nephew.On (b)(6) 2022, patient underwent a revision surgery.In his (b)(6) 2022 revision surgery, operative report, surgeon noted failure of right hip implant and metallosis of right hip joint.During surgery on (b)(6) 2022 but just prior to actual removal of patient's wright medical hip implant, surgeon followed a path of accumulated fluid down the back of patient's right hip and observed grey necrotic tissue in the back of the hip.After removal of the femoral head and the modular neck, surgeon noted "a significant amount of corrosion around the modular portion of the neck that mates with the stem.It is all blackened metallosis.It made black streaks on my glove pulling this out." surgeon was able to extract the modular neck from the stem with ease.During the (b)(6) 2022, revision surgery, surgeon removed the wright medical profemur® hip system, including the profemur® plus cocr modular neck and profemur® tl stem, as well as the conserve® femoral head and conserve® neck sleeve, all of which had been implanted in patient's right hip in 2012.These parts were then replaced with a femoral stem, femoral head, cup and liner, all manufactured by smith & nephew.Patient still experiences residual symptoms following the (b)(6) 2022, right hip revision surgery.Patient suffered a subsequent post-revision dislocation of his right hip on or about (b)(6) 2022.Surgeon has also determined that patient suffered significant posterior hip muscle loss, bone loss, loss of abductor function, and impairment of patient's gait and right hip stability.It was indicated on litigation file that patient's profemur® plus cocr modular neck suffered "micromotion, fretting corrosion, galvanic corrosion, and fracture".Also, it was indicated that 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.

Manufacturer Narrative

Mom investigation was removed because investigation by the engineer was needed.

• Brand Name: CONSERVE® TOTAL A-CLASS® 40MM FEMORAL HEAD
• Type of Device: 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: 15419192
• MDR Text Key: 299930551
• Report Number: 3010536692-2022-00333
• Device Sequence Number: 1
• Product Code: JDL
• UDI-Device Identifier: M68438AC40001
• UDI-Public: M68438AC40001
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K051348
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 10/21/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/14/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Other
• Device Model Number: 38AC4000
• Device Catalogue Number: 38AC4000
• Device Lot Number: 1451060
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 08/23/2022
• Date Manufacturer Received: 08/23/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention