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	1675	1677
Device Dislodged or Dislocated	433	433
Fracture	233	233
Osseointegration Problem	170	170
Appropriate Term/Code Not Available	133	133
Break	127	127
Difficult to Insert	114	114
Loosening of Implant Not Related to Bone-Ingrowth	91	91
Patient Device Interaction Problem	72	72
Detachment of Device or Device Component	69	69
Naturally Worn	68	68
Loss of or Failure to Bond	66	66
Migration	46	46
Loss of Osseointegration	45	45
Insufficient Information	35	35
Unstable	34	34
Positioning Failure	25	25
Use of Device Problem	17	17
Material Deformation	16	16
Device-Device Incompatibility	13	13
Device Damaged Prior to Use	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
Mechanical Problem	6	6
Material Erosion	6	6
Defective Device	6	6
Packaging Problem	6	6
Material Twisted/Bent	6	6
Device Appears to Trigger Rejection	5	5
Inadequacy of Device Shape and/or Size	5	5
Degraded	5	5
Therapeutic or Diagnostic Output Failure	5	5
Positioning Problem	5	5
Device Markings/Labelling Problem	5	5
Material Separation	4	4
Corroded	4	4
Failure to Advance	4	4
Difficult to Remove	3	3
Unintended Movement	3	3
Patient-Device Incompatibility	3	3
Separation Failure	3	3

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
Unspecified Infection	715	715
Pain	650	650
No Clinical Signs, Symptoms or Conditions	353	353
Joint Dislocation	338	338
No Code Available	334	334
Joint Laxity	284	284
Insufficient Information	276	276
Unspecified Tissue Injury	229	229
Inadequate Osseointegration	216	216
Failure of Implant	180	180
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available	176	176
Bone Fracture(s)	154	154
Loss of Range of Motion	137	137
Muscular Rigidity	41	41
Fall	41	41
Osteolysis	40	40
Implant Pain	39	39
Hematoma	38	38
Foreign Body Reaction	35	35
No Information	35	35
No Known Impact Or Consequence To Patient	34	34
Nerve Damage	32	32
Muscle/Tendon Damage	32	32
Discomfort	31	31
Limited Mobility Of The Implanted Joint	31	31
No Consequences Or Impact To Patient	30	30
Ossification	26	26
Unspecified Musculoskeletal problem	25	25
Inflammation	23	23
Adhesion(s)	19	19
Metal Related Pathology	17	17
Bacterial Infection	16	16
Foreign Body In Patient	15	15
Hypersensitivity/Allergic reaction	15	15
Pneumonia	14	14
Not Applicable	14	14
Fatigue	13	13
Erosion	13	15
Subluxation	12	12
Injury	12	12
Tissue Damage	12	12
Sepsis	11	11
Scar Tissue	10	10
Numbness	10	10
Pulmonary Embolism	9	9
Post Operative Wound Infection	8	8
Swelling/ Edema	8	8
Fluid Discharge	7	7
No Patient Involvement	7	7
Non-union Bone Fracture	7	7

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