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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

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Device prosthesis, hip, hemi-, acetabular, cemented, metal
Regulation Description Hip joint (hemi-hip) acetabular metal cemented prosthesis.
Definition Call for PMAs 12/26/96 (61 FR 50710 (9/27/96))
Product CodeKWB
Regulation Number 888.3370
Device Class 3

Device Problems
Implant, removal of 1645
Component(s), worn 935
Loose 718
Dislocated 416
Naturally worn 226
Unknown (for use when the device problem is not known) 172
Explanted 165
Other (for use when an appropriate device code cannot be identified) 125
No Information 97
Dislodged or dislocated 78
Disassembly 71
Break 53
Device remains implanted 49
Failure to osseointegrate 41
Malposition of device 41
Fracture 40
Loss of osseointegration 36
Loss of or failure to bond 24
Fitting problem 19
Loose or intermittent connection 18
Component(s), broken 15
Disengaged 15
Device, or device fragments remain in patient 15
Metal shedding debris 15
Migration of device or device component 10
Device Issue 7
No code available 7
Malfunction 6
No Known Device Problem 5
Failure to Adhere or Bond 5
Foreign material 4
Displacement 4
Defective component 4
Incomplete or missing packaging 2
Implant, repositioning of 2
Defective item 2
Sticking 2
Device inoperable 1
Unraveled material 1
Unstable 1
Use of Device Issue 1
Misassembled 1
Noise 1
Size incorrect for patient 1
Slippage of device or device component 1
Incorrect measurement 1
Mechanical issue 1
Membrane tear(s) 1
Device expiration issue 1
Interference 1
Bent 1
Detachment of device component 1
Component incompatible 1
Degraded 1
Device or device fragments location unknown 1
Computer system security issue 1
Device markings issue 1
Unintended movement 1
Material integrity issue 1
Tear, rip or hole in device packaging 1
Structural problem 1
Failure to align 1
Component missing 1
Device damaged prior to use 1
Total Device Problems 5116

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