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U.S. Department of Health and Human Services

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

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MICROPORT ORTHOPEDICS INC. CONSERVE® PLUS CUP HIP COMPONENT Back to Search Results
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. ?.
 
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Brand NameCONSERVE® PLUS CUP
Type of DeviceHIP 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 Key13719699
MDR Text Key286918331
Report Number3010536692-2022-00071
Device Sequence Number1
Product Code KWA
Combination Product (y/n)N
Reporter Country CodeUS
Number of Events Reported1
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 Received03/10/2022
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Model Number38025258
Device Catalogue Number38025258
Device Lot Number125290522
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? No
Distributor Facility Aware Date02/16/2022
Date Manufacturer Received02/16/2022
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Is the Device Single Use? Yes

Patient Treatment Data
Date Received: 03/10/2022 Patient Sequence Number: 1
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