TPLC - Total Product Life Cycle

• Device: prosthesis, shoulder, hemi-, humeral, metallic uncemented
• Product Code: HSD
• Regulation Number: 888.3690
• Device Class: 2

Premarket Reviews
Manufacturer	Decision
ARTHREX INC.
	SUBSTANTIALLY EQUIVALENT	2
ARTHROSURFACE, INC.
	SUBSTANTIALLY EQUIVALENT	1
BIOCORE9, LLC.
	SUBSTANTIALLY EQUIVALENT	1
IMPLANTCAST GMBH
	SUBSTANTIALLY EQUIVALENT	1

MDR Year	MDR Reports	MDR Events
2018	649	649
2019	829	829
2020	658	658
2021	574	574
2022	509	509
2023	592	592
2024	231	231

Device Problems	MDRs with this Device Problem	Events in those MDRs
Adverse Event Without Identified Device or Use Problem	1752	1752
Device Dislodged or Dislocated	591	591
Insufficient Information	260	260
Fracture	245	245
Appropriate Term/Code Not Available	193	193
Osseointegration Problem	145	145
Loss of Osseointegration	135	135
Break	135	135
Naturally Worn	110	110
Difficult to Insert	105	105
Detachment of Device or Device Component	80	80
Loosening of Implant Not Related to Bone-Ingrowth	76	76
Loss of or Failure to Bond	69	69
Unstable	54	54
Loose or Intermittent Connection	49	49
Migration	45	45
Patient Device Interaction Problem	38	38
Material Deformation	25	25
Migration or Expulsion of Device	24	24
Device-Device Incompatibility	20	20
Malposition of Device	20	20
Use of Device Problem	19	19
Material Erosion	18	18
Noise, Audible	18	18
Positioning Problem	15	15
Off-Label Use	15	15
Inadequacy of Device Shape and/or Size	14	14
Patient-Device Incompatibility	12	12
Manufacturing, Packaging or Shipping Problem	12	12
Packaging Problem	12	12
Fitting Problem	11	11
Failure to Osseointegrate	9	9
Inaccurate Information	9	9
Tear, Rip or Hole in Device Packaging	8	8
Mechanical Jam	8	8
Difficult to Advance	7	7
Connection Problem	7	7
Device Damaged Prior to Use	7	7
Mechanical Problem	7	7
Disassembly	7	7
Failure To Adhere Or Bond	7	7
Crack	7	7
Positioning Failure	6	6
Difficult to Remove	6	6
Failure to Advance	6	6
Material Twisted/Bent	6	6
Material Split, Cut or Torn	6	6
Therapeutic or Diagnostic Output Failure	6	6
Separation Problem	5	5
Device Markings/Labelling Problem	5	5
Component Missing	5	5
Unintended System Motion	5	5
Device Slipped	4	4
Difficult or Delayed Positioning	4	4
Defective Component	4	4
Microbial Contamination of Device	4	4
Unintended Movement	4	4
Separation Failure	3	3
Contamination /Decontamination Problem	3	3
Device Contaminated During Manufacture or Shipping	3	3
Detachment Of Device Component	3	3
Corroded	3	3
Material Fragmentation	3	3
Material Separation	3	3
Device Appears to Trigger Rejection	3	3
Nonstandard Device	2	2
Unexpected Therapeutic Results	2	2
Metal Shedding Debris	2	2
Material Disintegration	2	2
Entrapment of Device	2	2
Output Problem	2	2
Dull, Blunt	2	2
No Apparent Adverse Event	2	2
Physical Resistance/Sticking	2	2
Component Misassembled	2	2
Premature Separation	1	1
Protective Measures Problem	1	1
Failure to Disconnect	1	1
Defective Device	1	1
Biocompatibility	1	1
Solder Joint Fracture	1	1
Improper or Incorrect Procedure or Method	1	1
Activation, Positioning or Separation Problem	1	1
Compatibility Problem	1	1
Disconnection	1	1
Decoupling	1	1
Degraded	1	1
Material Rupture	1	1
Delivered as Unsterile Product	1	1
Misassembled	1	1
Unsealed Device Packaging	1	1

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
No Code Available	982	982
Pain	925	925
Unspecified Infection	879	879
Joint Dislocation	488	488
No Clinical Signs, Symptoms or Conditions	266	266
Inadequate Osseointegration	246	246
Not Applicable	215	215
Joint Laxity	199	199
Loss of Range of Motion	191	191
Bone Fracture(s)	177	177
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available	174	174
Failure of Implant	160	160
Insufficient Information	158	158
Unspecified Tissue Injury	130	130
No Information	122	122
No Consequences Or Impact To Patient	119	119
No Known Impact Or Consequence To Patient	84	84
Hematoma	83	83
Limited Mobility Of The Implanted Joint	73	73
Discomfort	63	63
Injury	58	58
Osteolysis	56	56
Fall	52	52
Muscular Rigidity	47	47
Tissue Damage	40	40
Nerve Damage	38	38
Joint Disorder	34	34
Foreign Body Reaction	28	28
Ossification	26	26
Implant Pain	26	26
Muscle/Tendon Damage	23	23
Unspecified Musculoskeletal problem	22	22
Inflammation	22	22
Adhesion(s)	20	20
Bacterial Infection	19	19
Stroke/CVA	19	19
Death	19	19
Erosion	18	18
Hypersensitivity/Allergic reaction	17	17
Numbness	16	16
Foreign Body In Patient	14	14
Patient Problem/Medical Problem	14	14
Pneumonia	14	14
Fatigue	13	13
Scar Tissue	12	12
Swelling	12	12
Subluxation	12	12
No Patient Involvement	11	11
Sepsis	11	11
Pulmonary Embolism	11	11
Osteopenia/ Osteoporosis	9	9
Post Operative Wound Infection	9	9
Reaction	9	9
Impaired Healing	8	8
Metal Related Pathology	8	8
Swelling/ Edema	7	7
Fluid Discharge	7	7
Arthritis	7	7
Edema	7	7
Cyst(s)	6	6
Rheumatoid Arthritis	6	6
Pocket Erosion	6	6
Ambulation Difficulties	6	6
Device Embedded In Tissue or Plaque	5	5
Fracture, Arm	5	5
Muscle Weakness	5	5
Neurological Deficit/Dysfunction	5	5
Seroma	5	5
Synovitis	5	5
Weakness	4	4
Non-union Bone Fracture	4	4
Disability	4	4
Muscle Hypotonia	4	4
Thrombosis/Thrombus	4	4
Limb Fracture	3	3
Paresthesia	3	3
Unspecified Mental, Emotional or Behavioural Problem	3	3
Arthralgia	3	3
Rupture	3	3
Abscess	3	3
Debris, Bone Shedding	3	3
Fever	3	3
Erythema	2	2
Wound Dehiscence	2	2
Angina	2	2
Arrhythmia	2	2
Calcium Deposits/Calcification	2	2
Cardiac Arrest	2	2
Burning Sensation	2	2
Tingling	2	2
Thrombosis	2	2
Staphylococcus Aureus	2	2
Pulmonary Edema	2	2
Inadequate Pain Relief	2	2
Ischemic Heart Disease	2	2
Fibrosis	2	2
Cognitive Changes	2	2
Thromboembolism	2	2
Tissue Breakdown	2	2
Heart Failure/Congestive Heart Failure	2	2

Recalls
Manufacturer		Recall Class	Date Posted
1	Ascension Orthopedics, Inc	III	Feb-02-2019
2	DePuy Orthopaedics, Inc.	II	Mar-01-2018
3	Exactech, Inc.	II	Jan-22-2021
4	Fx Solutions	II	Jul-17-2018
5	Zimmer Biomet, Inc.	II	Mar-13-2018