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	1862	1874
Device Dislodged or Dislocated	457	460
Fracture	254	256
Osseointegration Problem	195	196
Appropriate Term/Code Not Available	133	138
Break	130	130
Difficult to Insert	123	124
Loosening of Implant Not Related to Bone-Ingrowth	99	100
Patient Device Interaction Problem	91	91
Naturally Worn	77	79
Detachment of Device or Device Component	76	77
Loss of or Failure to Bond	68	68
Loss of Osseointegration	50	50
Migration	48	48
Insufficient Information	37	37
Unstable	35	37
Positioning Failure	32	32
Material Deformation	19	19
Use of Device Problem	17	17
Device-Device Incompatibility	13	13
Device Damaged Prior to Use	13	13
No Apparent Adverse Event	12	12
Tear, Rip or Hole in Device Packaging	12	12
Off-Label Use	12	12
Loose or Intermittent Connection	12	12
Manufacturing, Packaging or Shipping Problem	12	12
Noise, Audible	10	10
Inaccurate Information	9	9
Crack	9	9
Malposition of Device	9	10
Difficult to Advance	8	8
Defective Device	7	7
Mechanical Problem	7	7
Material Erosion	6	6
Material Twisted/Bent	6	7
Packaging Problem	6	6
Material Split, Cut or Torn	6	6
Therapeutic or Diagnostic Output Failure	5	5
Positioning Problem	5	5
Degraded	5	6
Device Appears to Trigger Rejection	5	5
Device Markings/Labelling Problem	5	5
Inadequacy of Device Shape and/or Size	5	5
Corroded	4	4
Failure to Advance	4	4
Material Separation	4	4
Difficult to Remove	3	3
Connection Problem	3	3
Unintended Movement	3	3
Patient-Device Incompatibility	3	3

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
Unspecified Infection	793	796
Pain	693	700
No Clinical Signs, Symptoms or Conditions	388	393
Joint Dislocation	355	358
No Code Available	334	334
Joint Laxity	316	319
Insufficient Information	306	307
Unspecified Tissue Injury	270	270
Inadequate Osseointegration	243	244
Failure of Implant	194	195
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available	178	178
Bone Fracture(s)	172	172
Loss of Range of Motion	142	142
Osteolysis	44	45
Implant Pain	44	45
Muscular Rigidity	41	41
Fall	41	41
Hematoma	39	39
Muscle/Tendon Damage	38	38
Foreign Body Reaction	37	41
No Information	35	35
No Known Impact Or Consequence To Patient	34	34
Discomfort	33	33
Nerve Damage	32	32
Limited Mobility Of The Implanted Joint	31	31
No Consequences Or Impact To Patient	30	30
Ossification	28	28
Metal Related Pathology	27	27
Unspecified Musculoskeletal problem	26	26
Inflammation	23	23
Adhesion(s)	19	19
Foreign Body In Patient	17	17
Hypersensitivity/Allergic reaction	17	17
Bacterial Infection	17	17
Subluxation	17	17
Not Applicable	14	14
Pneumonia	14	14
Fatigue	13	13
Erosion	13	15
Tissue Damage	12	12
Injury	12	12
Sepsis	11	11
Scar Tissue	10	10
Numbness	10	10
Swelling/ Edema	10	10
Pulmonary Embolism	9	9
Post Operative Wound Infection	8	8
Fluid Discharge	7	7
Limb Fracture	7	7
Non-union Bone Fracture	7	7

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