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	879	883
Device Dislodged or Dislocated	433	436
Detachment of Device or Device Component	387	388
Naturally Worn	252	253
Loosening of Implant Not Related to Bone-Ingrowth	249	253
Fracture	216	217
Unstable	151	151
Insufficient Information	115	115
Break	82	82
Migration	39	39
Patient Device Interaction Problem	35	35
Appropriate Term/Code Not Available	26	27
Mechanical Problem	26	26
Lack of Effect	25	25
Loss of or Failure to Bond	24	24
Structural Problem	21	21
Noise, Audible	12	12
Unintended Movement	12	12
Inadequacy of Device Shape and/or Size	10	10
Material Erosion	9	9
Material Deformation	6	6
Loss of Osseointegration	5	5
Misassembly by Users	5	5
Patient-Device Incompatibility	4	4
Difficult to Insert	4	4
Defective Device	3	3
Positioning Problem	3	3
Contamination /Decontamination Problem	3	3
Separation Failure	3	3
Material Fragmentation	3	3
Material Twisted/Bent	3	3
Crack	3	3
Malposition of Device	3	3
Loose or Intermittent Connection	3	3
Separation Problem	3	3
Fitting Problem	2	2
Biocompatibility	2	2
Manufacturing, Packaging or Shipping Problem	2	2
Material Integrity Problem	2	2
Unintended Collision	2	2
Activation, Positioning or Separation Problem	2	2
Degraded	2	2
Use of Device Problem	2	2
Osseointegration Problem	2	2
Improper or Incorrect Procedure or Method	2	2
Off-Label Use	2	2
Inaccurate Information	2	2
Migration or Expulsion of Device	2	2
Device-Device Incompatibility	2	2
Mechanical Jam	1	1

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
Failure of Implant	539	541
Pain	490	493
Joint Dislocation	415	416
Insufficient Information	386	387
Unspecified Infection	210	210
Joint Laxity	180	181
Bacterial Infection	163	163
Bone Fracture(s)	143	143
Loss of Range of Motion	128	130
Muscle/Tendon Damage	108	110
Metal Related Pathology	106	106
No Clinical Signs, Symptoms or Conditions	103	103
Osteolysis	77	77
Implant Pain	70	70
Subluxation	46	46
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available	45	45
Inadequate Osseointegration	38	38
Discomfort	27	27
Fall	17	17
Unspecified Tissue Injury	17	17
Erosion	17	17
Limb Fracture	16	16
No Code Available	14	14
No Information	14	14
Swelling/ Edema	13	13
No Consequences Or Impact To Patient	13	13
Inflammation	12	12
Osteopenia/ Osteoporosis	11	11
Purulent Discharge	9	9
Device Embedded In Tissue or Plaque	8	8
Foreign Body In Patient	8	8
Fluid Discharge	7	7
Adhesion(s)	6	6
Unspecified Musculoskeletal problem	6	6
Erythema	6	6
Ossification	6	6
Necrosis	5	5
Muscle Weakness	5	5
Diarrhea	5	5
Numbness	5	5
Nerve Damage	5	5
Abdominal Pain	5	5
Weight Changes	5	5
Wound Dehiscence	5	5
Hematoma	4	4
Scar Tissue	4	4
No Known Impact Or Consequence To Patient	4	4
Arthritis	4	4
Heart Failure/Congestive Heart Failure	3	3
Ambulation Difficulties	3	3

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