TPLC - Total Product Life Cycle

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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	843	847
Device Dislodged or Dislocated	415	418
Detachment of Device or Device Component	365	366
Loosening of Implant Not Related to Bone-Ingrowth	248	252
Naturally Worn	240	241
Fracture	211	212
Unstable	140	140
Insufficient Information	111	111
Break	81	81
Migration	35	35
Patient Device Interaction Problem	28	28
Appropriate Term/Code Not Available	26	27
Mechanical Problem	25	25
Lack of Effect	24	24
Loss of or Failure to Bond	23	23
Structural Problem	15	15
Noise, Audible	11	11
Inadequacy of Device Shape and/or Size	9	9
Material Erosion	8	8
Unintended Movement	7	7
Material Deformation	6	6
Loss of Osseointegration	5	5
Misassembly by Users	5	5
Patient-Device Incompatibility	4	4
Difficult to Insert	4	4
Loose or Intermittent Connection	3	3
Material Twisted/Bent	3	3
Material Fragmentation	3	3
Contamination /Decontamination Problem	3	3
Defective Device	3	3
Positioning Problem	3	3
Separation Failure	3	3
Crack	3	3
Malposition of Device	3	3
Separation Problem	3	3
Manufacturing, Packaging or Shipping Problem	2	2
Degraded	2	2
Use of Device Problem	2	2
Material Integrity Problem	2	2
Off-Label Use	2	2
Migration or Expulsion of Device	2	2
Inaccurate Information	2	2
Activation, Positioning or Separation Problem	2	2
Improper or Incorrect Procedure or Method	2	2
Fitting Problem	2	2
Device-Device Incompatibility	2	2
Biocompatibility	2	2
Unintended Collision	2	2
Difficult to Remove	1	1
Unsealed Device Packaging	1	1

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
Failure of Implant	537	539
Pain	471	474
Joint Dislocation	395	396
Insufficient Information	361	362
Unspecified Infection	193	193
Joint Laxity	165	166
Bacterial Infection	163	163
Bone Fracture(s)	139	139
Loss of Range of Motion	124	126
Metal Related Pathology	102	102
No Clinical Signs, Symptoms or Conditions	100	100
Muscle/Tendon Damage	90	92
Osteolysis	76	76
Implant Pain	67	67
Subluxation	46	46
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available	44	44
Inadequate Osseointegration	38	38
Discomfort	22	22
Unspecified Tissue Injury	17	17
Fall	17	17
Limb Fracture	16	16
No Information	14	14
No Code Available	14	14
Erosion	14	14
Swelling/ Edema	13	13
No Consequences Or Impact To Patient	13	13
Inflammation	12	12
Osteopenia/ Osteoporosis	11	11
Device Embedded In Tissue or Plaque	8	8
Purulent Discharge	8	8
Fluid Discharge	7	7
Foreign Body In Patient	7	7
Unspecified Musculoskeletal problem	6	6
Adhesion(s)	6	6
Erythema	6	6
Ossification	6	6
Necrosis	5	5
Wound Dehiscence	5	5
Numbness	5	5
Muscle Weakness	5	5
Weight Changes	5	5
Abdominal Pain	5	5
Nerve Damage	5	5
Diarrhea	5	5
No Known Impact Or Consequence To Patient	4	4
Hematoma	4	4
Ambulation Difficulties	3	3
Injury	3	3
Granuloma	3	3
Arthritis	3	3

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