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	1830	1842
Device Dislodged or Dislocated	377	380
Fracture	241	243
Osseointegration Problem	224	225
Patient Device Interaction Problem	107	107
Difficult to Insert	101	102
Loosening of Implant Not Related to Bone-Ingrowth	92	93
Break	89	89
Naturally Worn	69	70
Detachment of Device or Device Component	56	57
Loss of or Failure to Bond	55	55
Migration	46	46
Unstable	41	43
Positioning Failure	33	33
Appropriate Device Problem Term/Code Not Available	27	31
Insufficient Device Problem Information	22	22
Material Deformation	20	20
Loss of Osseointegration	17	17
Use of Device Problem	16	16
No Apparent Adverse Event	15	15
Device Damaged Prior to Use	12	12
Off-Label Use	11	11
Inaccurate Information	9	9
Tear, Rip or Hole in Device Packaging	8	8
Noise, Audible	8	8
Crack	8	8
Difficult to Advance	7	7
Device-Device Incompatibility	7	7
Defective Device	6	6
Mechanical Problem	6	6
Device Appears to Trigger Rejection	6	6
Device Markings/Labelling Problem	5	5
Degraded	5	6
Improper or Incorrect Procedure or Method	5	5
Material Twisted/Bent	5	6
Inadequacy of Device Shape and/or Size	5	5
Packaging Problem	5	5
Malposition of Device	4	5
Material Erosion	4	4
Failure to Advance	4	4
Corroded	4	4
Separation Failure	3	3
Residue After Decontamination	3	3
Fitting Problem	3	3
Component Misassembled	3	3
Material Separation	3	3
Positioning Problem	3	3
Manufacturing, Packaging or Shipping Problem	3	3
Device Contaminated During Manufacture or Shipping	3	3
Connection Problem	3	3

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
Unspecified Infection	791	794
Pain	607	614
No Clinical Signs, Symptoms or Conditions	411	416
Joint Laxity	360	363
Insufficient Information	347	348
Unspecified Tissue Injury	320	320
Joint Dislocation	300	303
Inadequate Osseointegration	236	237
Bone Fracture(s)	180	180
Failure of Implant	175	176
Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available	149	149
Loss of Range of Motion	134	134
Implant Pain	49	50
Muscle/Tendon Damage	48	48
Osteolysis	37	38
Medical device site infection	35	35
Muscular Rigidity	34	34
Nerve Damage	34	34
Hematoma	33	33
Foreign Body Reaction	32	36
Extraskeletal ossification	28	28
Fall	27	27
Unspecified Musculoskeletal problem	26	26
Metal Related Pathology	26	26
Subluxation	23	23
Foreign Body In Patient	21	21
Hypersensitivity/Allergic reaction	20	20
Discomfort	20	20
Aseptic loosening	19	19
Inflammation	16	16
Periprosthetic fracture	14	14
Fatigue	13	13
Bacterial Infection	12	12
Erosion	12	14
Adhesion(s)	11	11
Swelling/ Edema	11	11
Sepsis	11	11
Bone Notching	11	11
Scar Tissue	9	9
Joint Impingement	9	9
Post Operative Wound Infection	9	9
Numbness	9	9
Nonunion/Delayed-union Bone Fracture	8	8
Pulmonary Embolism	7	7
Septic loosening	7	7
Limb Fracture	7	7
Fluid Discharge	7	7
Rheumatoid Arthritis	6	6
Pneumonia	6	6
Connective Tissue Disease	6	6

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