TPLC - Total Product Life Cycle

• Device: prosthesis, knee, femorotibial, semi-constrained, cemented, metal/polymer
• Product Code: HRY
• Regulation Number: 888.3530
• Device Class: 2

Premarket Reviews
Manufacturer	Decision
DEPUY IRELAND UC
	SUBSTANTIALLY EQUIVALENT	1
NANOORTHO, LLC
	SUBSTANTIALLY EQUIVALENT	1

MDR Year	MDR Reports	MDR Events
2019	367	367
2020	1055	1055
2021	1219	1219
2022	842	842
2023	401	401
2024	125	125

Device Problems	MDRs with this Device Problem	Events in those MDRs
Break	1436	1436
Fracture	500	500
Adverse Event Without Identified Device or Use Problem	377	377
Insufficient Information	210	210
Loosening of Implant Not Related to Bone-Ingrowth	208	208
Naturally Worn	146	146
Crack	141	141
Detachment of Device or Device Component	131	131
Unstable	127	127
Loose or Intermittent Connection	80	80
Material Deformation	69	69
Connection Problem	64	64
Loss of Osseointegration	57	57
Appropriate Term/Code Not Available	53	53
Device Dislodged or Dislocated	46	46
Positioning Failure	44	44
Material Fragmentation	41	41
Component Missing	40	40
Defective Device	39	39
Mechanical Jam	39	39
Dull, Blunt	37	37
Mechanical Problem	37	37
Difficult to Insert	30	30
Material Separation	28	28
Migration	28	28
Patient Device Interaction Problem	24	24
Loss of or Failure to Bond	23	23
Incomplete or Inadequate Connection	22	22
Material Twisted/Bent	22	22
Device Contamination with Chemical or Other Material	21	21
Malposition of Device	21	21
Noise, Audible	20	20
Unintended Movement	20	20
Material Integrity Problem	16	16
Patient-Device Incompatibility	16	16
Physical Resistance/Sticking	15	15
Device Markings/Labelling Problem	14	14
Device-Device Incompatibility	14	14
Device Reprocessing Problem	12	12
Degraded	11	11
Mechanics Altered	11	11
Corroded	10	10
Contamination /Decontamination Problem	9	9
Separation Failure	9	9
Improper or Incorrect Procedure or Method	9	9
Use of Device Problem	8	8
Flaked	8	8
Inadequacy of Device Shape and/or Size	7	7
Failure to Align	7	7
Osseointegration Problem	7	7
Fitting Problem	6	6
Material Discolored	6	6
Positioning Problem	5	5
No Apparent Adverse Event	5	5
Component Misassembled	5	5
Premature Separation	5	5
Packaging Problem	4	4
Peeled/Delaminated	4	4
Misassembled	4	4
Device Damaged Prior to Use	4	4
Tear, Rip or Hole in Device Packaging	4	4
Solder Joint Fracture	4	4
Failure to Disconnect	4	4
Biocompatibility	3	3
Structural Problem	3	3
Shipping Damage or Problem	3	3
Difficult to Remove	3	3
Material Too Rigid or Stiff	3	3
Nonstandard Device	3	3
Delivered as Unsterile Product	3	3
Off-Label Use	3	3
Scratched Material	3	3
Material Split, Cut or Torn	3	3
Device Fell	2	2
Difficult or Delayed Separation	2	2
No Fail-Safe Mechanism	2	2
Device Contaminated During Manufacture or Shipping	2	2
Manufacturing, Packaging or Shipping Problem	2	2
Material Puncture/Hole	2	2
Device Appears to Trigger Rejection	2	2
Unsealed Device Packaging	2	2
Material Erosion	2	2
Failure to Charge	2	2
Device Slipped	2	2
Unexpected Therapeutic Results	2	2
Failure to Osseointegrate	2	2
Activation, Positioning or Separation Problem	2	2
Device Damaged by Another Device	2	2
Deformation Due to Compressive Stress	1	1
Failure to Calibrate	1	1
Residue After Decontamination	1	1
Suction Problem	1	1
Burst Container or Vessel	1	1
Complete Blockage	1	1
Insufficient Heating	1	1
Disconnection	1	1
Failure to Disinfect	1	1
Material Disintegration	1	1
Entrapment of Device	1	1
Migration or Expulsion of Device	1	1

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
No Clinical Signs, Symptoms or Conditions	2280	2280
Pain	348	348
No Known Impact Or Consequence To Patient	200	200
Unspecified Infection	189	189
No Consequences Or Impact To Patient	165	165
No Patient Involvement	164	164
Insufficient Information	157	157
Failure of Implant	153	153
No Information	150	150
No Code Available	130	130
Ambulation Difficulties	98	98
Loss of Range of Motion	70	70
Swelling/ Edema	70	70
Joint Laxity	63	63
Injury	60	60
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available	36	36
Joint Dislocation	34	34
Bone Fracture(s)	32	32
Synovitis	27	27
Foreign Body In Patient	21	21
Not Applicable	21	21
Osteolysis	20	20
Swelling	17	17
Inadequate Osseointegration	17	17
Muscular Rigidity	16	16
Inflammation	14	14
Adhesion(s)	13	13
Scar Tissue	13	13
Discomfort	12	12
Fall	12	12
Hypersensitivity/Allergic reaction	12	12
Post Operative Wound Infection	11	11
Arthritis	10	10
Metal Related Pathology	10	10
Joint Disorder	9	9
Reaction	7	7
Limited Mobility Of The Implanted Joint	7	7
Device Embedded In Tissue or Plaque	7	7
Thrombosis/Thrombus	6	6
Ossification	6	6
Fatigue	6	6
Hemorrhage/Bleeding	6	6
Implant Pain	6	6
Unspecified Tissue Injury	5	5
Cyst(s)	5	5
Osteopenia/ Osteoporosis	5	5
Fluid Discharge	4	4
Numbness	4	4
Laceration(s)	4	4
Cellulitis	4	4
Subluxation	4	4
Unspecified Musculoskeletal problem	3	3
Perforation	3	3
Damage to Ligament(s)	3	3
Autoimmune Reaction	3	3
Bacterial Infection	3	3
Pulmonary Embolism	3	3
Arthralgia	3	3
Fibrosis	3	3
Patient Problem/Medical Problem	2	2
Inadequate Pain Relief	2	2
Sepsis	2	2
Tissue Damage	2	2
Muscle Weakness	2	2
Low Blood Pressure/ Hypotension	2	2
Renal Failure	2	2
Pocket Erosion	1	1
Necrosis	1	1
Syncope	1	1
Abdominal Pain	1	1
Abrasion	1	1
Aspiration/Inhalation	1	1
Autoimmune Disorder	1	1
Erosion	1	1
Calcium Deposits/Calcification	1	1
Edema	1	1
Embolism	1	1
Foreign Body Reaction	1	1
Burning Sensation	1	1
Hip Fracture	1	1
Neck Stiffness	1	1
Deformity/ Disfigurement	1	1
Non-union Bone Fracture	1	1
Tissue Breakdown	1	1
Alteration In Body Temperature	1	1
Hormonal Imbalance	1	1
Breast Discomfort/Pain	1	1
Unspecified Immune System Problem	1	1
Muscle/Tendon Damage	1	1

Recalls
Manufacturer		Recall Class	Date Posted
1	Aesculap Implant Systems LLC	II	Sep-22-2021
2	Biomet, Inc.	II	Jan-26-2023
3	Biomet, Inc.	II	Dec-17-2020
4	Biomet, Inc.	II	May-28-2020
5	Exactech, Inc.	II	Oct-04-2021
6	MicroPort Orthopedics Inc.	II	Nov-22-2022