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	1726	1738
Device Dislodged or Dislocated	367	370
Fracture	223	225
Osseointegration Problem	201	202
Patient Device Interaction Problem	102	102
Difficult to Insert	95	96
Break	93	93
Loosening of Implant Not Related to Bone-Ingrowth	88	89
Appropriate Term/Code Not Available	83	88
Naturally Worn	69	71
Loss of or Failure to Bond	53	53
Detachment of Device or Device Component	49	50
Migration	43	43
Unstable	41	43
Positioning Failure	32	32
Insufficient Information	22	22
Material Deformation	19	19
Loss of Osseointegration	17	17
Use of Device Problem	14	14
No Apparent Adverse Event	13	13
Device Damaged Prior to Use	12	12
Off-Label Use	11	11
Inaccurate Information	9	9
Tear, Rip or Hole in Device Packaging	9	9
Noise, Audible	8	8
Device-Device Incompatibility	7	7
Crack	7	7
Difficult to Advance	7	7
Mechanical Problem	6	6
Device Appears to Trigger Rejection	6	6
Defective Device	6	6
Loose or Intermittent Connection	5	5
Inadequacy of Device Shape and/or Size	5	5
Packaging Problem	5	5
Degraded	5	6
Malposition of Device	5	6
Device Markings/Labelling Problem	5	5
Material Twisted/Bent	4	5
Corroded	4	4
Material Erosion	4	4
Fitting Problem	3	3
Device Contaminated During Manufacture or Shipping	3	3
Therapeutic or Diagnostic Output Failure	3	3
Positioning Problem	3	3
Connection Problem	3	3
Failure to Advance	3	3
Material Separation	3	3
Manufacturing, Packaging or Shipping Problem	3	3
Residue After Decontamination	3	3
Component Misassembled	3	3

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
Unspecified Infection	735	738
Pain	569	576
No Clinical Signs, Symptoms or Conditions	388	393
Joint Laxity	328	331
Insufficient Information	313	314
Unspecified Tissue Injury	301	301
Joint Dislocation	285	288
Inadequate Osseointegration	213	214
Failure of Implant	175	176
Bone Fracture(s)	165	165
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available	149	149
Loss of Range of Motion	123	123
Implant Pain	46	47
Muscle/Tendon Damage	42	42
Osteolysis	37	38
Muscular Rigidity	34	34
Hematoma	33	33
Foreign Body Reaction	32	36
Nerve Damage	31	31
Ossification	28	28
Metal Related Pathology	26	26
Fall	25	25
Unspecified Musculoskeletal problem	23	23
Hypersensitivity/Allergic reaction	20	20
Subluxation	20	20
Discomfort	19	19
Foreign Body In Patient	17	17
Inflammation	16	16
Bacterial Infection	13	13
Fatigue	13	13
Erosion	12	14
Swelling/ Edema	11	11
Adhesion(s)	11	11
Sepsis	10	10
Scar Tissue	9	9
Numbness	9	9
Post Operative Wound Infection	8	8
Limb Fracture	7	7
Fluid Discharge	7	7
Non-union Bone Fracture	7	7
Pulmonary Embolism	7	7
Pneumonia	6	6
Decreased Sensitivity	6	6
Wound Dehiscence	6	6
Neuropathy	6	6
Connective Tissue Disease	6	6
Cyst(s)	5	5
Rheumatoid Arthritis	5	5
Seroma	5	5
Fibrosis	5	5

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