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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: WRIGHT MEDICAL TECHNOLOGY DYNASTY PC SHELL HIP IMPLANT

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WRIGHT MEDICAL TECHNOLOGY DYNASTY PC SHELL HIP IMPLANT Back to Search Results
Catalog Number DSPC-GE54
Device Problems Failure to Osseointegrate (1863); Appropriate Term/Code Not Available (3191)
Patient Problems Nerve Damage (1979); Pain (1994); Urticaria (2278); Toxicity (2333)
Event Date 06/16/2009
Event Type  Injury  
Event Description
Wright medical conserve mom resurfacing needed to be revised to thr. Socket was loose and out of position. No bony in-growth with the socket. Damage to acetabular pelvic bone required bone grafting to seat new socket. Presence of modest metallosis. Symptomatic signs of cobalt/chromium toxicity, urticaria. Extended rehab with lasting chronic pain. Revised hip had to be replaced (b)(6) 2011 due to socket failure to integrate with the bone. Socket was loose and out of position, causing intense pain. Revision was long and complicated, required trochanteric osteotomy blood transfusion, 5 months of physical therapy, compromised quality of life. The x-ray and neurolagic exam were pending at the time of this dictation. Indications: the pt will be (b)(6) next month. She has severe hip pain and effusion. She also has nerve damage in her leg from a spinal problem. She wished to go forward with hip resurfacing procedure. Naturally, this could aggravate her underlying neuropathy from a double crush concern. She would not gain the full functional results that others might because of the underlying neurologic issue. We might have difficulty with position of the components, infection, deep venous thrombosis, femoral neck fracture, dislocation, prosthetic loosening, metal ion release. She accepted these risks and wished to proceed. I did speak with her husband prior to the procedure as well. Operative findings: she had large joint effusion, substantial degenerative changes on the articular cartilage, good quality bone. Her plain films were not particularly impressive but the ct scan had shown the issue and confirmed the actual surgical findings. Posterolateral approach to the hip was performed and the hip was dislocated posteriorly. We then prepared the femur to accept a 46-mm femoral component from the conserve plus from wright medical. The acetabulum was prepared to accept a 52-mm shell also from wright medical, also the conserve plus. With the femur cemented in place the hip was reduced, placed through range of motion, found to be stable and secure. We irrigated the wound, closed the posterior capsule with #5 suture and the fascia with running maxon followed by ultimately clips in the skin. Sterile dressing was applied. Abduction pillow was applied. The pt was released to the recovery room in satisfactory condition having tolerated the procedure well.
 
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Brand NameDYNASTY PC SHELL
Type of DeviceHIP IMPLANT
Manufacturer (Section D)
WRIGHT MEDICAL TECHNOLOGY
MDR Report Key2614889
MDR Text Key19663633
Report NumberMW5025761
Device Sequence Number3
Product Code LPH
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Voluntary
Reporter Occupation
Type of Report Initial
Report Date 05/28/2012
10 Devices were Involved in the Event: 1   2   3   4   5   6   7   8   9   10  
1 Patient was Involved in the Event
Date FDA Received06/07/2012
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date03/01/2017
Device Catalogue NumberDSPC-GE54
Device Lot Number039817177
Is the Reporter a Health Professional? No
Is This a Reprocessed and Reused Single-Use Device? No

Patient Treatment Data
Date Received: 06/07/2012 Patient Sequence Number: 1
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