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	1000	1004
Device Dislodged or Dislocated	453	454
Detachment of Device or Device Component	432	433
Naturally Worn	301	302
Loosening of Implant Not Related to Bone-Ingrowth	268	270
Fracture	234	235
Unstable	172	172
Insufficient Device Problem Information	127	127
Break	68	68
Migration	44	44
Patient Device Interaction Problem	39	39
Mechanical Problem	31	31
Lack of Effect	29	29
Loss of or Failure to Bond	27	27
Structural Problem	26	26
Noise, Audible	15	15
Unintended Movement	12	12
Loss of Osseointegration	10	10
Material Erosion	10	10
Appropriate Device Problem Term/Code Not Available	10	11
Inadequacy of Device Shape and/or Size	9	9
Material Deformation	9	9
Misassembly by Users	6	6
Separation Failure	5	5
Difficult to Insert	4	4
Device-Device Incompatibility	3	3
Separation Problem	3	3
Osseointegration Problem	3	3
Crack	3	3
Defective Device	3	3
Contamination /Decontamination Problem	3	3
Material Fragmentation	3	3
Use of Device Problem	3	3
Biocompatibility	2	2
Unintended Collision	2	2
Inaccurate Information	2	2
No Apparent Adverse Event	2	2
Device Difficult to Setup or Prepare	2	2
Implant subsidence	2	2
Degraded	2	2
Damaged Thread	2	2
Positioning Problem	2	2
Material Integrity Problem	2	2
Manufacturing, Packaging or Shipping Problem	2	2
Malposition of Device	2	2
Off-Label Use	2	2
Migration or Expulsion of Device	2	2
Failure to Align	1	1
Material Twisted/Bent	1	1
Scratched Material	1	1

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
Pain	573	576
Failure of Implant	540	542
Joint Dislocation	456	457
Insufficient Information	453	454
Unspecified Infection	266	266
Joint Laxity	208	209
Bacterial Infection	163	163
Bone Fracture(s)	162	162
Loss of Range of Motion	149	151
Metal Related Pathology	135	135
Muscle/Tendon Damage	132	134
No Clinical Signs, Symptoms or Conditions	122	122
Osteolysis	98	98
Implant Pain	73	73
Medical device site infection	59	59
Aseptic loosening	59	59
Subluxation	49	49
Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available	46	46
Inadequate Osseointegration	42	42
Discomfort	31	31
Joint Impingement	30	30
Arthropathy	27	27
Periprosthetic fracture	25	25
Unspecified Tissue Injury	22	22
Erosion	20	20
Fall	18	18
Limb Fracture	17	17
Swelling/ Edema	15	15
No Code Available	14	14
No Information	14	14
No Consequences Or Impact To Patient	13	13
Inflammation	13	13
Post Operative Wound Infection	12	12
Osteopenia/ Osteoporosis	12	12
Septic loosening	11	11
Bone Notching	10	10
Numbness	10	10
Foreign Body In Patient	9	9
Purulent Discharge	9	9
Hematoma	8	8
Device Embedded In Tissue or Plaque	8	8
Nerve Damage	7	7
Muscle Weakness/Atrophy	7	7
Fluid Discharge	7	7
Adhesion(s)	6	6
Unspecified Musculoskeletal problem	6	6
Extraskeletal ossification	6	6
Joint effusion	6	6
Erythema	6	6
Diarrhea	5	5

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