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	856	860
Device Dislodged or Dislocated	425	428
Detachment of Device or Device Component	409	410
Naturally Worn	279	280
Loosening of Implant Not Related to Bone-Ingrowth	241	245
Fracture	221	222
Unstable	164	164
Insufficient Information	120	120
Break	65	65
Migration	39	39
Patient Device Interaction Problem	36	36
Mechanical Problem	31	31
Lack of Effect	26	26
Loss of or Failure to Bond	25	25
Structural Problem	23	23
Appropriate Term/Code Not Available	13	14
Noise, Audible	12	12
Unintended Movement	11	11
Inadequacy of Device Shape and/or Size	10	10
Material Deformation	7	7
Material Erosion	6	6
Loss of Osseointegration	5	5
Separation Failure	5	5
Patient-Device Incompatibility	4	4
Misassembly by Users	4	4
Defective Device	3	3
Positioning Problem	3	3
Osseointegration Problem	3	3
Separation Problem	3	3
Material Fragmentation	3	3
Difficult to Insert	3	3
Use of Device Problem	3	3
Malposition of Device	3	3
Crack	3	3
Fitting Problem	2	2
Unintended Collision	2	2
Activation, Positioning or Separation Problem	2	2
Improper or Incorrect Procedure or Method	2	2
Device-Device Incompatibility	2	2
Off-Label Use	2	2
No Apparent Adverse Event	2	2
Material Twisted/Bent	2	2
Device Difficult to Setup or Prepare	2	2
Degraded	2	2
Material Integrity Problem	2	2
Manufacturing, Packaging or Shipping Problem	2	2
Migration or Expulsion of Device	1	1
Audible Prompt/Feedback Problem	1	1
Misassembled	1	1
Peeled/Delaminated	1	1

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
Pain	510	513
Failure of Implant	489	491
Insufficient Information	428	429
Joint Dislocation	402	403
Unspecified Infection	242	242
Joint Laxity	197	198
Bone Fracture(s)	146	146
Loss of Range of Motion	134	136
Bacterial Infection	130	130
Metal Related Pathology	125	125
Muscle/Tendon Damage	117	119
No Clinical Signs, Symptoms or Conditions	114	114
Osteolysis	90	90
Implant Pain	71	71
Subluxation	48	48
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available	44	44
Inadequate Osseointegration	34	34
Discomfort	31	31
Unspecified Tissue Injury	20	20
Limb Fracture	17	17
Erosion	15	15
Fall	15	15
Swelling/ Edema	12	12
Inflammation	11	11
Osteopenia/ Osteoporosis	11	11
Purulent Discharge	9	9
Foreign Body In Patient	9	9
Numbness	8	8
Muscle Weakness	7	7
Fluid Discharge	7	7
Post Operative Wound Infection	7	7
Nerve Damage	7	7
Unspecified Musculoskeletal problem	6	6
Adhesion(s)	6	6
Hematoma	6	6
Erythema	6	6
Wound Dehiscence	5	5
Necrosis	5	5
Arthritis	5	5
Scar Tissue	5	5
Ossification	5	5
Weight Changes	5	5
Abdominal Pain	5	5
Diarrhea	5	5
Solid Tumour	3	3
Granuloma	3	3
Heart Failure/Congestive Heart Failure	3	3
Immobility of the joint	2	2
Non-union Bone Fracture	2	2
Abscess	2	2

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