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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MICROPORT ORTHOPEDICS INC. CONSERVE® A-CLASS® BFH® HEAD MEDIUM NECK 48MM HIP COMPONENT

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MICROPORT ORTHOPEDICS INC. CONSERVE® A-CLASS® BFH® HEAD MEDIUM NECK 48MM HIP COMPONENT Back to Search Results
Model Number 38AM4800
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Osteolysis (2377); Metal Related Pathology (4530)
Event Type  Injury  
Event Description
Allegedly, in the revision surgery the dr noted that there was a large soft tissue mass (pseudotumor) in the posterior aspect of the hip capsule and external rotators additional that there was a significant amount of metal-stained tissue involving synovium, capsule and bone in both, femur and acetabulum, that he removed an excessive amount of membranes, metallosis and osteolytic soft tissue. Because the hip stem was well fixed, an extended trochanteric osteotomy was required to remove the profemur® plasma z stem in plaintiff's left hip and removed all of the wright medical devices that had been implanted in plaintiff's left hip, except for the conserve® plus spiked cup, which was well fixed and left in place. In (b)(6) 2021 plaintiff developed adverse symptoms including, but not limited to, progressively worsening pain in and around his hip joints. In (b)(6) 2021 an mri demonstrated large fluid filled collections over both of plaintiff's hips. In (b)(6) 2021 laboratory tests also revealed that plaintiffs cobalt and chromium levels in his blood were significantly elevated.
 
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Brand NameCONSERVE® A-CLASS® BFH® HEAD MEDIUM NECK 48MM
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 Key14375128
MDR Text Key291507864
Report Number3010536692-2022-00180
Device Sequence Number1
Product Code KWA
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K021349
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Other,Foreign
Reporter Occupation
Type of Report Initial
Report Date 05/12/2022
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received05/12/2022
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Model Number38AM4800
Device Catalogue Number38AM4800
Device Lot Number0101029702
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? No
Distributor Facility Aware Date04/19/2022
Date Manufacturer Received04/19/2022
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Is the Device Single Use? Yes

Patient Treatment Data
Date Received: 05/12/2022 Patient Sequence Number: 1
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