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	2001	2013
Device Dislodged or Dislocated	466	469
Fracture	264	266
Osseointegration Problem	209	210
Appropriate Term/Code Not Available	133	138
Break	131	131
Difficult to Insert	124	125
Patient Device Interaction Problem	105	105
Loosening of Implant Not Related to Bone-Ingrowth	104	105
Naturally Worn	78	80
Detachment of Device or Device Component	77	78
Loss of or Failure to Bond	70	70
Loss of Osseointegration	54	54
Migration	52	52
Unstable	41	43
Insufficient Information	37	37
Positioning Failure	34	34
Material Deformation	19	19
Use of Device Problem	17	17
Device-Device Incompatibility	13	13
No Apparent Adverse Event	13	13
Device Damaged Prior to Use	13	13
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	11	11
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
Device Appears to Trigger Rejection	6	6
Material Erosion	6	6
Material Twisted/Bent	6	7
Material Split, Cut or Torn	6	6
Packaging Problem	6	6
Inadequacy of Device Shape and/or Size	6	6
Positioning Problem	5	5
Therapeutic or Diagnostic Output Failure	5	5
Degraded	5	6
Device Markings/Labelling Problem	5	5
Corroded	4	4
Failure to Advance	4	4
Material Separation	4	4
Difficult to Remove	3	3
Unintended Movement	3	3
Connection Problem	3	3
Patient-Device Incompatibility	3	3

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
Unspecified Infection	844	847
Pain	727	734
No Clinical Signs, Symptoms or Conditions	401	406
Joint Dislocation	359	362
Joint Laxity	341	344
No Code Available	334	334
Insufficient Information	322	323
Unspecified Tissue Injury	301	301
Inadequate Osseointegration	258	259
Failure of Implant	201	202
Bone Fracture(s)	189	189
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available	178	178
Loss of Range of Motion	144	144
Osteolysis	46	47
Implant Pain	46	47
Muscle/Tendon Damage	43	43
Fall	42	42
Muscular Rigidity	41	41
Hematoma	39	39
Foreign Body Reaction	38	42
No Information	35	35
No Known Impact Or Consequence To Patient	34	34
Discomfort	34	34
Nerve Damage	32	32
Limited Mobility Of The Implanted Joint	31	31
No Consequences Or Impact To Patient	30	30
Ossification	30	30
Metal Related Pathology	27	27
Unspecified Musculoskeletal problem	26	26
Inflammation	23	23
Hypersensitivity/Allergic reaction	20	20
Subluxation	20	20
Adhesion(s)	19	19
Foreign Body In Patient	18	18
Bacterial Infection	17	17
Erosion	14	16
Fatigue	14	14
Pneumonia	14	14
Not Applicable	14	14
Swelling/ Edema	12	12
Tissue Damage	12	12
Injury	12	12
Sepsis	11	11
Scar Tissue	10	10
Numbness	10	10
Pulmonary Embolism	9	9
Post Operative Wound Infection	8	8
No Patient Involvement	7	7
Fluid Discharge	7	7
Limb Fracture	7	7

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