TPLC - Total Product Life Cycle

show TPLC since

Device	prosthesis, shoulder, non-constrained, metal/polymer cemented
Regulation Description	Shoulder joint metal/polymer non-constrained cemented prosthesis.
Product Code	KWT
Regulation Number	888.3650
Device Class	2

Device Problems	MDRs with this Device Problem	Events in those MDRs
Adverse Event Without Identified Device or Use Problem	794	798
Device Dislodged or Dislocated	411	414
Detachment of Device or Device Component	381	382
Naturally Worn	255	256
Loosening of Implant Not Related to Bone-Ingrowth	232	236
Fracture	208	209
Unstable	150	150
Insufficient Information	115	115
Break	65	65
Migration	38	38
Patient Device Interaction Problem	36	36
Mechanical Problem	27	27
Lack of Effect	26	26
Loss of or Failure to Bond	24	24
Structural Problem	22	22
Appropriate Term/Code Not Available	13	14
Noise, Audible	11	11
Unintended Movement	11	11
Inadequacy of Device Shape and/or Size	9	9
Material Deformation	6	6
Material Erosion	5	5
Patient-Device Incompatibility	4	4
Misassembly by Users	3	3
Use of Device Problem	3	3
Difficult to Insert	3	3
Positioning Problem	3	3
Defective Device	3	3
Separation Failure	3	3
Crack	3	3
Malposition of Device	3	3
Separation Problem	3	3
Material Integrity Problem	2	2
Material Fragmentation	2	2
Manufacturing, Packaging or Shipping Problem	2	2
Material Twisted/Bent	2	2
Off-Label Use	2	2
Device-Device Incompatibility	2	2
Improper or Incorrect Procedure or Method	2	2
Osseointegration Problem	2	2
Activation, Positioning or Separation Problem	2	2
Unintended Collision	2	2
Fitting Problem	2	2
Unsealed Device Packaging	1	1
Measurement System Incompatibility	1	1
Contamination /Decontamination Problem	1	1
Degraded	1	1
Failure to Align	1	1
Difficult to Advance	1	1
Material Puncture/Hole	1	1
Audible Prompt/Feedback Problem	1	1

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
Failure of Implant	489	491
Pain	467	470
Insufficient Information	391	392
Joint Dislocation	387	388
Unspecified Infection	216	216
Joint Laxity	182	183
Bone Fracture(s)	135	135
Bacterial Infection	131	131
Loss of Range of Motion	127	129
Metal Related Pathology	109	109
Muscle/Tendon Damage	106	108
No Clinical Signs, Symptoms or Conditions	105	105
Osteolysis	75	75
Implant Pain	69	69
Subluxation	47	47
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available	44	44
Inadequate Osseointegration	32	32
Discomfort	29	29
Unspecified Tissue Injury	19	19
Limb Fracture	16	16
Erosion	14	14
Fall	14	14
Inflammation	11	11
Swelling/ Edema	11	11
Osteopenia/ Osteoporosis	10	10
Purulent Discharge	9	9
Foreign Body In Patient	8	8
Fluid Discharge	7	7
Numbness	7	7
Nerve Damage	7	7
Erythema	6	6
Adhesion(s)	6	6
Unspecified Musculoskeletal problem	6	6
Arthritis	5	5
Diarrhea	5	5
Wound Dehiscence	5	5
Ossification	5	5
Abdominal Pain	5	5
Muscle Weakness	5	5
Necrosis	5	5
Hematoma	5	5
Weight Changes	5	5
Scar Tissue	4	4
Granuloma	3	3
Heart Failure/Congestive Heart Failure	3	3
Solid Tumour	3	3
Easy Bruising	2	2
Ambulation Difficulties	2	2
Cognitive Changes	2	2
Post Operative Wound Infection	2	2

Recalls
Manufacturer		Recall Class	Date Posted
1	Exactech, Inc.	II	Jan-18-2024