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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: STRYKER 40 MM POLYETHYLENE LINER
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STRYKER 40 MM POLYETHYLENE LINER Back to Search Results
Device Problem Patient-Device Incompatibility (2682)
Patient Problems Pulmonary Embolism (1498); Anemia (1706); Hypersensitivity/Allergic reaction (1907); Pain (1994); Disability (2371); Test Result (2695)
Event Type  No Answer Provided  
Event Description
Difficult recovery from total hip replacement surgery (b)(6) 2009.Pulmonary embolism, pneumonia, iron saturation drop from 100% to 40%.After a year, i was doing okay.In (b)(6) 2011 experiencing pain at site.Four cortisone shots did not help.Had surgery for bursar sac removal, now i ams experiencing the same problems.Pain restricts my activities.No longer can attend aerobics or exercise classes.Do not have enough strength in left hip to climb stairs.Attempts cause pain also.Further surgery has not been ruled out.Neither has the diagnosis of another bursar sac been ruled out.At last office visit with doctor, i was told 'many others have the same problem.' first, what is the problem? my own conclusion is that as i have many allergies, i am allergic to the plastic or some other part of the components in my hip replacement.At this rate, each two or three years, i will have hip surgery and pain to look forward to.Have others made similar complaints about this medical device? thank you.Twenty one months after hip replacement surgery (b)(6) 2011, i had surgery in the same place as i had very painful bursar sac removed.Entire original incision excised.Same problem now continues.
 
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Brand Name
40 MM POLYETHYLENE LINER
Type of Device
POLYETHYLENE LINER
Manufacturer (Section D)
STRYKER
MDR Report Key3600219
MDR Text Key4168575
Report NumberMW5034073
Device Sequence Number3
Product Code JDI
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Voluntary
Reporter Occupation Other
Type of Report Initial
5 Devices were Involved in the Event: 1   2   3   4   5  
1 Patient was Involved in the Event
Date FDA Received01/24/2014
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator Lay User/Patient
Patient Sequence Number1
Treatment
FLUTICASONE, 4 INHALATIONS PER DAY; 1 SENIOR MULTI-VITAMIN; 1 GLIPIZIDE, 10 MG; DULCALAX; CALCIUM WITH D, ZINC, MAGNESIUM, 1600 MG PER DAY; 3000 MCG. XR VITAMIN B-12; 1 LEVOTHYROXINE, 50 MCG; 1 PROVASTATIN 40 MG; 1, 325 MG. ASPIRIN; QVAR 80 MCG, 4 INHALATIONS PER DAY; 2, 600 MG GABAPENTIN; METFORMIN 4, 500 ER MG; 1 OSTEO-BIFLEX TRIPLE STRENGTH; NIACIN 500 MG; 1400 MG OMEGA-3; 1, 200 MCG. SELENIUM; 1 TOPROL XL 25 MG; FIBERCON; SINGULAR , 1 PER DAY; 2000 MG XR VITAMIN C
Patient Outcome(s) Other;
Patient Weight84
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