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	225	225

Device Problems	MDRs with this Device Problem	Events in those MDRs
Break	1446	1446
Fracture	538	538
Adverse Event Without Identified Device or Use Problem	382	382
Insufficient Information	220	220
Loosening of Implant Not Related to Bone-Ingrowth	210	210
Detachment of Device or Device Component	153	153
Naturally Worn	148	148
Crack	141	141
Unstable	127	127
Loose or Intermittent Connection	80	80
Material Deformation	70	70
Connection Problem	64	64
Loss of Osseointegration	61	61
Appropriate Term/Code Not Available	53	53
Positioning Failure	48	48
Device Dislodged or Dislocated	47	47
Material Fragmentation	45	45
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
Material Twisted/Bent	22	22
Incomplete or Inadequate Connection	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
Degraded	13	13
Device Reprocessing Problem	12	12
Corroded	11	11
Separation Failure	11	11
Mechanics Altered	11	11
Contamination /Decontamination Problem	9	9
Improper or Incorrect Procedure or Method	9	9
Use of Device Problem	8	8
Failure to Align	8	8
Flaked	8	8
Inadequacy of Device Shape and/or Size	7	7
Osseointegration Problem	7	7
Fitting Problem	6	6
Material Discolored	6	6
Packaging Problem	5	5
Positioning Problem	5	5
No Apparent Adverse Event	5	5
Component Misassembled	5	5
Premature Separation	5	5
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
Device Damaged by Another Device	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
Material Split, Cut or Torn	3	3
Scratched Material	3	3
No Fail-Safe Mechanism	2	2
Device Contaminated During Manufacture or Shipping	2	2
Manufacturing, Packaging or Shipping Problem	2	2
Device Fell	2	2
Difficult or Delayed Separation	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
Deformation Due to Compressive Stress	2	2
Failure to Calibrate	1	1
Residue After Decontamination	1	1
Suction Problem	1	1
Burst Container or Vessel	1	1
Complete Blockage	1	1
Difficult or Delayed Positioning	1	1
Insufficient Heating	1	1
Disconnection	1	1
Failure to Disinfect	1	1
Material Disintegration	1	1
Entrapment of Device	1	1

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
No Clinical Signs, Symptoms or Conditions	2352	2352
Pain	356	356
No Known Impact Or Consequence To Patient	200	200
Unspecified Infection	197	197
No Consequences Or Impact To Patient	165	165
No Patient Involvement	164	164
Insufficient Information	162	162
Failure of Implant	159	159
No Information	150	150
No Code Available	130	130
Ambulation Difficulties	98	98
Loss of Range of Motion	72	72
Swelling/ Edema	71	71
Joint Laxity	63	63
Injury	60	60
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available	36	36
Joint Dislocation	35	35
Bone Fracture(s)	32	32
Synovitis	27	27
Foreign Body In Patient	23	23
Osteolysis	22	22
Not Applicable	21	21
Swelling	17	17
Inadequate Osseointegration	17	17
Inflammation	16	16
Muscular Rigidity	16	16
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
Device Embedded In Tissue or Plaque	9	9
Reaction	7	7
Limited Mobility Of The Implanted Joint	7	7
Ossification	6	6
Fatigue	6	6
Hemorrhage/Bleeding	6	6
Thrombosis/Thrombus	6	6
Implant Pain	6	6
Unspecified Tissue Injury	5	5
Cyst(s)	5	5
Osteopenia/ Osteoporosis	5	5
Tissue Breakdown	4	4
Numbness	4	4
Fluid Discharge	4	4
Laceration(s)	4	4
Cellulitis	4	4
Subluxation	4	4
Unspecified Musculoskeletal problem	3	3
Blister	3	3
Perforation	3	3
Damage to Ligament(s)	3	3
Low Blood Pressure/ Hypotension	3	3
Autoimmune Reaction	3	3
Bacterial Infection	3	3
Pulmonary Embolism	3	3
Fibrosis	3	3
Arthralgia	3	3
Inadequate Pain Relief	2	2
Sepsis	2	2
Renal Failure	2	2
Tissue Damage	2	2
Patient Problem/Medical Problem	2	2
Muscle Weakness	2	2
Pneumonia	1	1
Pocket Erosion	1	1
Necrosis	1	1
Nerve Damage	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
Unspecified Immune System Problem	1	1
Neck Stiffness	1	1
Alteration In Body Temperature	1	1
Burning Sensation	1	1
Rupture	1	1
Deformity/ Disfigurement	1	1
Non-union Bone Fracture	1	1
Hip Fracture	1	1
Muscle/Tendon Damage	1	1
Hormonal Imbalance	1	1
Breast Discomfort/Pain	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	Jul-01-2024
7	MicroPort Orthopedics Inc.	II	Nov-22-2022