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	668	668
Device Dislodged or Dislocated	311	311
Loosening of Implant Not Related to Bone-Ingrowth	204	204
Detachment of Device or Device Component	173	173
Fracture	164	164
Naturally Worn	111	111
Break	74	74
Insufficient Information	70	70
Unstable	57	57
Appropriate Term/Code Not Available	25	25
Patient Device Interaction Problem	20	20
Migration	19	19
Loss of or Failure to Bond	10	10
Inadequacy of Device Shape and/or Size	9	9
Material Erosion	8	8
Mechanical Problem	7	7
Unintended Movement	6	6
Lack of Effect	6	6
Loss of Osseointegration	4	4
Patient-Device Incompatibility	4	4
Difficult to Insert	4	4
Noise, Audible	3	3
Loose or Intermittent Connection	3	3
Misassembly by Users	3	3
Contamination /Decontamination Problem	3	3
Defective Device	3	3
Malposition of Device	3	3
Activation, Positioning or Separation Problem	3	3
Positioning Problem	2	2
Material Fragmentation	2	2
Material Integrity Problem	2	2
Manufacturing, Packaging or Shipping Problem	2	2
Separation Failure	2	2
Off-Label Use	2	2
Migration or Expulsion of Device	2	2
Separation Problem	2	2
Inaccurate Information	2	2
Improper or Incorrect Procedure or Method	2	2
Unintended Collision	2	2
Biocompatibility	2	2
Fitting Problem	2	2
Measurement System Incompatibility	1	1
Unsealed Device Packaging	1	1
Difficult to Remove	1	1
Degraded	1	1
Use of Device Problem	1	1
Failure to Align	1	1
Material Twisted/Bent	1	1
Device Fell	1	1
Misassembled	1	1

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
Failure of Implant	543	543
Joint Dislocation	268	268
Pain	246	246
Insufficient Information	208	208
Bacterial Infection	165	165
Bone Fracture(s)	121	121
Unspecified Infection	110	110
No Clinical Signs, Symptoms or Conditions	78	78
Loss of Range of Motion	66	66
Joint Laxity	54	54
Muscle/Tendon Damage	47	47
Osteolysis	29	29
Metal Related Pathology	26	26
Implant Pain	24	24
Subluxation	22	22
Inadequate Osseointegration	19	19
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available	16	16
Fall	15	15
Erosion	14	14
No Code Available	14	14
No Information	14	14
No Consequences Or Impact To Patient	13	13
Unspecified Tissue Injury	12	12
Swelling/ Edema	10	10
Device Embedded In Tissue or Plaque	8	8
Purulent Discharge	7	7
Osteopenia/ Osteoporosis	7	7
Foreign Body In Patient	6	6
Necrosis	5	5
Inflammation	5	5
Wound Dehiscence	5	5
Fluid Discharge	5	5
Weight Changes	5	5
Diarrhea	5	5
Abdominal Pain	5	5
Hematoma	4	4
Limb Fracture	4	4
Numbness	4	4
No Known Impact Or Consequence To Patient	4	4
Erythema	4	4
Nerve Damage	4	4
Unspecified Musculoskeletal problem	3	3
Heart Failure/Congestive Heart Failure	3	3
Ossification	3	3
Injury	3	3
Discomfort	3	3
Non-union Bone Fracture	2	2
Tissue Damage	2	2
Arthritis	2	2
Granuloma	2	2

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