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	1639	1641
Device Dislodged or Dislocated	423	423
Fracture	225	225
Osseointegration Problem	166	166
Appropriate Term/Code Not Available	133	133
Break	124	124
Difficult to Insert	110	110
Loosening of Implant Not Related to Bone-Ingrowth	85	85
Patient Device Interaction Problem	70	70
Detachment of Device or Device Component	69	69
Naturally Worn	68	68
Loss of or Failure to Bond	57	57
Loss of Osseointegration	45	45
Migration	44	44
Insufficient Information	35	35
Unstable	34	34
Positioning Failure	25	25
Material Deformation	16	16
Use of Device Problem	16	16
Device Damaged Prior to Use	13	13
Device-Device Incompatibility	13	13
Off-Label Use	12	12
Loose or Intermittent Connection	12	12
Manufacturing, Packaging or Shipping Problem	12	12
Tear, Rip or Hole in Device Packaging	11	11
Noise, Audible	10	10
Inaccurate Information	9	9
Malposition of Device	9	9
Crack	9	9
Difficult to Advance	8	8
No Apparent Adverse Event	7	7
Material Split, Cut or Torn	6	6
Defective Device	6	6
Packaging Problem	6	6
Material Twisted/Bent	6	6
Material Erosion	6	6
Device Appears to Trigger Rejection	5	5
Inadequacy of Device Shape and/or Size	5	5
Therapeutic or Diagnostic Output Failure	5	5
Positioning Problem	5	5
Mechanical Problem	5	5
Degraded	5	5
Device Markings/Labelling Problem	5	5
Failure to Advance	4	4
Material Separation	4	4
Corroded	4	4
Component Misassembled	3	3
Separation Failure	3	3
Patient-Device Incompatibility	3	3
Unintended Movement	3	3

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
Unspecified Infection	696	696
Pain	641	641
No Clinical Signs, Symptoms or Conditions	342	342
Joint Dislocation	334	334
No Code Available	334	334
Joint Laxity	276	276
Insufficient Information	259	259
Unspecified Tissue Injury	213	213
Inadequate Osseointegration	212	212
Failure of Implant	181	181
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available	176	176
Bone Fracture(s)	150	150
Loss of Range of Motion	135	135
Muscular Rigidity	41	41
Fall	41	41
Osteolysis	40	40
Hematoma	38	38
Implant Pain	36	36
No Information	35	35
No Known Impact Or Consequence To Patient	34	34
Muscle/Tendon Damage	32	32
Nerve Damage	32	32
Limited Mobility Of The Implanted Joint	31	31
Discomfort	31	31
No Consequences Or Impact To Patient	30	30
Foreign Body Reaction	29	29
Ossification	26	26
Inflammation	22	22
Unspecified Musculoskeletal problem	22	22
Adhesion(s)	19	19
Metal Related Pathology	17	17
Bacterial Infection	16	16
Hypersensitivity/Allergic reaction	15	15
Pneumonia	14	14
Not Applicable	14	14
Foreign Body In Patient	13	13
Fatigue	13	13
Erosion	13	15
Tissue Damage	12	12
Injury	12	12
Subluxation	12	12
Sepsis	11	11
Scar Tissue	10	10
Numbness	10	10
Pulmonary Embolism	9	9
Swelling/ Edema	8	8
Post Operative Wound Infection	8	8
No Patient Involvement	7	7
Fluid Discharge	7	7
Non-union Bone Fracture	7	7

Recalls
Manufacturer		Recall Class	Date Posted
1	Exactech, Inc.	II	Jan-22-2021