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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: SMITH AND NEPHEW, INC. SCREW REFLECTION SPHERICAL HEAD 15MM PROSTHESIS,HIP SEMI-CONSTRAINED,UNCEMENTED METAL/POLYER,NON-POROUS,CALCIUM PHOSP

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SMITH AND NEPHEW, INC. SCREW REFLECTION SPHERICAL HEAD 15MM PROSTHESIS,HIP SEMI-CONSTRAINED,UNCEMENTED METAL/POLYER,NON-POROUS,CALCIUM PHOSP Back to Search Results
Lot Number 16LM11733
Device Problems Break (1069); Device Dislodged or Dislocated (2923)
Patient Problems Arthritis (1723); Unspecified Infection (1930); Pain (1994); Swelling (2091); Discomfort (2330)
Event Date 07/19/2019
Event Type  Injury  
Event Description
Infected total joint in (b)(6) 2018. Spacer and then replaced in (b)(6) 2018. Left hip prosthesis stem broke in (b)(6) 2019. Arthritis left hip, hip(left) replacement 2009, infection left hip (b)(6) 2018. Left spur with 3mm, replaced again; (b)(6) 2018 broke and replaced again in (b)(6) 2019. I am writing with some concerns in reference t total hip replacements i myself have had several done with some complications that are questionable. I have enclosed a description of what has happened to me and would like it reviewed with some consideration. I originally had a total left hip replacement back in 2009. I had no problems and felt terrific. No problems with the recovery time and was able to go back to work without any extra delay, just the 9 - 10 weeks time off. As time went on then about 5 years later, i had to have a total right hip replacement. Once again this went off without any difficulties, no additional time off work needed, returned without any restrictions. I was going along well then in (b)(6) 2018, i started having some severe lower back pain that had left the doctors perplexed at first. They were treating me for lumbago or possibly sciatic pain. All attempts to treat the issue went unfounded. I continued to have pain and in trying to reduce the swelling in the back, i was sent to a chiropractor for treatment. While there the left hip dislocated, no direct pressure, no falls, no trauma, nothing that could pin- point why this occurred. I was taken to surgery to have it reduced and during that time labs were drawn and found to have some elevation in values. The following morning once again the hip dislocated and back to surgery i went. At this time the joint was aspirated and found to be infected. They did this due to the elevated lab values from the night prior. After the infection was found i was sent on to an orthopedic specialist and i was found to have a total joint full of infection. I had to have the joint removed, antibiotic permeated spacer placed and no weight bearing for 8 weeks, before being able to have the total joint replaced then in (b)(6) 2018. Some how the spacer bent during the bedrest, no weight bearing time period. The physician stated that he had not seen that happen into many instances. I lost a large amount of work time due to this situation, almost lost my job. I returned to work in (b)(6) 2018. Upon returning to work all was going well as expected from the (b)(6) 2018 until (b)(6) 2019 the left hip replacement dislocated and needed to be reduced 5 times. This was a painful and stressful time that was unexpected. Then in (b)(6) 2019 the femoral stem component of the prosthesis was found to be broken clear in two. Of course, once again surgery, another new total left hip replacement done. I spent 8-9 weeks no weight bearing, and the healing is progressing well without any problems. I have obtained all the information that i could on the equipment used in all the surgeries and would like to have this reviewed to see if there were any possible recalls. I believe the hardware that was used in the second total left hip replacement after the infection was defective. I went through a great deal of pain and anguish and all the doctors say is it was malfunctioning hardware. I do not believe that this is acceptable and i feel that the items need to be reviewed that are enclosed. Please investigate the hardware to see if any recalls or anything were applicable. I certainly would hate to have others go through what i went through to no accord. If there is any compensation to be had}t would be much appreciated , due to increased pain and discomfort, the cost of multiple surgeries, need to stay in rehabilitation facility, physical therapy and finally loss of income. I have been dealing with this for far too long and would appreciate some consideration. Thank you so much for your time and help with this experience. Like i said please review and i would like to hear back from this letter. I enclosed the surgery report information with the lot numbers and dates of everything, plus i enclosed a copy of the x-ray of the fractured femoral stern.
 
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Brand NameSCREW REFLECTION SPHERICAL HEAD 15MM
Type of DevicePROSTHESIS,HIP SEMI-CONSTRAINED,UNCEMENTED METAL/POLYER,NON-POROUS,CALCIUM PHOSP
Manufacturer (Section D)
SMITH AND NEPHEW, INC.
MDR Report Key9601550
MDR Text Key176048185
Report NumberMW5092337
Device Sequence Number7
Product Code MEH
Combination Product (y/n)N
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Voluntary
Reporter Occupation
Type of Report Initial
Report Date 01/09/2020
11 Devices were Involved in the Event: 1   2   3   4   5   6   7   8   9   10   11  
1 Patient was Involved in the Event
Date FDA Received01/16/2020
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Lot Number16LM11733
Was Device Available for Evaluation? No Answer Provided
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Was Device Evaluated by Manufacturer?
Is the Device Single Use?
Is This a Reprocessed and Reused Single-Use Device?
Type of Device Usage

Patient Treatment Data
Date Received: 01/16/2020 Patient Sequence Number: 1
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