MAUDE Adverse Event Report: MICROPORT ORTHOPEDICS INC. CONSERVE® PLUS CUP; HIP COMPONENT

Model Number 38025258

Device Problem Patient-Device Incompatibility (2682)

Patient Problems Pain (1994); Metal Related Pathology (4530)

Event Type  Injury  

Event Description

Allegedly, patient started to experience pain in or around his left hip joint in (b)(6) 2019.Tests for cobalt blood levels drawn on (b)(6) 2020, showed an elevated cobalt level of 4.9 in the results received on (b)(6) 2020.On (b)(6) 2020, patient was diagnosed by dr.(b)(6) to have corrosion/metallosis wright medical femoral stem and recommended a revision surgery.On (b)(6) 2020, patients left hip was revised, resulting in removal and replacement of the previously implanted conserve hip.The operative note from the (b)(6) 2020, revision procedure references: failed left total hip replacement with pseudotumor and metallosis.? it was evident at this point that the large pseudotumor, which had been diagnosed by mri had tented the gluteus maximus.It measured approximately 4 x 4 cm.It was attached to the lateral proximal trochanter.? significant necrotic capsule and tissue.? corrosion extending from the head.?.

• Brand Name: CONSERVE® PLUS CUP
• 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: 13719699
• MDR Text Key: 286918331
• Report Number: 3010536692-2022-00071
• Device Sequence Number: 1
• Product Code: KWA
• Combination Product (y/n): N
• Reporter Country Code: US
• 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
• Report Date: 03/09/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/10/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 38025258
• Device Catalogue Number: 38025258
• Device Lot Number: 125290522
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 02/16/2022
• Date Manufacturer Received: 02/16/2022
• 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
• Patient Sex: Male