TPLC - Total Product Life Cycle

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Device	prosthesis, knee, femorotibial, non-constrained, cemented, metal/polymer
Regulation Description	Knee joint femorotibial metal/polymer non-constrained cemented prosthesis.
Product Code	HSX
Regulation Number	888.3520
Device Class	2

Device Problems
Insufficient Information	145
Adverse Event Without Identified Device or Use Problem	78
Fracture	35
Break	27
Migration or Expulsion of Device	25
Loosening of Implant Not Related to Bone-Ingrowth	16
Unstable	15
Appropriate Term/Code Not Available	14
Failure To Adhere Or Bond	13
Difficult to Insert	12
Loose or Intermittent Connection	11
Naturally Worn	9
Migration	7
Malposition of device	6
Device Dislodged or Dislocated	6
Device Contamination with Chemical or Other Material	4
No Apparent Adverse Event	4
Degraded	4
Noise, Audible	4
Physical Resistance / Sticking	3
Difficult To Position	3
Component Missing	3
Device Operates Differently Than Expected	3
Mechanical Problem	3
Packaging Problem	3
Material Twisted / Bent	3
Fitting Problem	2
Crack	2
Loss of or Failure to Bond	2
Device Contaminated during manufacture or shipping	2
Device Packaging Compromised	2
Positioning Failure	2
Device-Device Incompatibility	2
Detachment of Device or device Component	1
Scratched Material	1
Osseointegration Problem	1
Device Damaged Prior to Use	1
Off-Label Use	1
Improper or Incorrect Procedure or Method	1
Incomplete or Inadequate Connection	1
Contamination / decontamination Problem	1
Device Abrasion From Instrument Or Another Object	1
Misconnection	1
Mechanical Jam	1
Defective Device	1
Loss of Osseointegration	1
Inadequacy of Device Shape and/or Size	1
Detachment Of Device Component	1
Material Deformation	1
Unintended Movement	1
Incorrect Measurement	1
Material Integrity Problem	1
Peeled / Delaminated	1
Device Issue	1
Total Device Problems	491