TPLC - Total Product Life Cycle

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Device	prosthesis, shoulder, hemi-, humeral, metallic uncemented
Regulation Description	Shoulder joint humeral (hemi-shoulder) metallic uncemented prosthesis.
Product Code	HSD
Regulation Number	888.3690
Device Class	2

Device Problems	MDRs with this Device Problem	Events in those MDRs
Adverse Event Without Identified Device or Use Problem	2051	2053
Device Dislodged or Dislocated	579	579
Fracture	282	282
Osseointegration Problem	193	193
Appropriate Term/Code Not Available	160	160
Break	148	148
Difficult to Insert	124	124
Loss of Osseointegration	109	109
Loosening of Implant Not Related to Bone-Ingrowth	105	105
Naturally Worn	97	97
Detachment of Device or Device Component	85	85
Loss of or Failure to Bond	80	80
Insufficient Information	80	80
Patient Device Interaction Problem	72	72
Migration	55	55
Unstable	42	42
Positioning Failure	26	26
Use of Device Problem	24	24
Material Deformation	19	19
Device-Device Incompatibility	19	19
Loose or Intermittent Connection	16	16
Off-Label Use	15	15
Malposition of Device	15	15
Noise, Audible	14	14
Manufacturing, Packaging or Shipping Problem	13	13
Device Damaged Prior to Use	13	13
Material Erosion	11	11
Tear, Rip or Hole in Device Packaging	11	11
Packaging Problem	10	10
Inaccurate Information	9	9
Crack	9	9
Inadequacy of Device Shape and/or Size	9	9
Difficult to Advance	8	8
Fitting Problem	8	8
No Apparent Adverse Event	7	7
Patient-Device Incompatibility	6	6
Defective Device	6	6
Therapeutic or Diagnostic Output Failure	6	6
Failure to Advance	6	6
Migration or Expulsion of Device	6	6
Mechanical Problem	6	6
Mechanical Jam	6	6
Material Split, Cut or Torn	6	6
Material Twisted/Bent	6	6
Device Appears to Trigger Rejection	5	5
Positioning Problem	5	5
Difficult to Remove	5	5
Device Markings/Labelling Problem	5	5
Degraded	5	5
Material Separation	5	5

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
Unspecified Infection	986	986
No Code Available	866	866
Pain	838	838
Joint Dislocation	458	458
No Clinical Signs, Symptoms or Conditions	353	353
Joint Laxity	284	284
Inadequate Osseointegration	279	279
Insufficient Information	276	276
Unspecified Tissue Injury	231	231
Bone Fracture(s)	198	198
Failure of Implant	197	197
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available	178	178
Loss of Range of Motion	167	167
Hematoma	81	81
Not Applicable	78	78
No Consequences Or Impact To Patient	78	78
No Information	75	75
No Known Impact Or Consequence To Patient	67	67
Limited Mobility Of The Implanted Joint	56	56
Osteolysis	56	56
Injury	54	54
Discomfort	53	53
Fall	51	51
Muscular Rigidity	47	47
Foreign Body Reaction	41	41
Implant Pain	39	39
Nerve Damage	35	35
Muscle/Tendon Damage	32	32
Ossification	28	28
Tissue Damage	25	25
Unspecified Musculoskeletal problem	25	25
Inflammation	25	25
Adhesion(s)	22	22
Foreign Body In Patient	20	20
Stroke/CVA	19	19
Hypersensitivity/Allergic reaction	18	18
Bacterial Infection	18	18
Metal Related Pathology	17	17
Fatigue	15	15
Erosion	14	16
Pneumonia	14	14
Numbness	12	12
Scar Tissue	12	12
Subluxation	12	12
Sepsis	11	11
No Patient Involvement	11	11
Pulmonary Embolism	11	11
Swelling/ Edema	10	10
Osteopenia/ Osteoporosis	9	9
Post Operative Wound Infection	9	9