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
2018	613	613
2019	367	367
2020	1055	1055
2021	1222	1222
2022	850	850

Device Problems	MDRs with this Device Problem	Events in those MDRs
Break	1416	1416
Insufficient Information	377	377
Adverse Event Without Identified Device or Use Problem	373	373
Fracture	296	296
Loosening of Implant Not Related to Bone-Ingrowth	193	193
Naturally Worn	168	168
Crack	139	139
Loose or Intermittent Connection	132	132
Unstable	132	132
Appropriate Term/Code Not Available	120	120
Detachment of Device or Device Component	90	90
Device Dislodged or Dislocated	79	79
Material Deformation	68	68
Connection Problem	66	66
Loss of Osseointegration	51	51
Component Missing	41	41
Mechanical Problem	40	40
Material Fragmentation	39	39
Defective Device	39	39
Dull, Blunt	37	37
Mechanical Jam	36	36
Difficult to Insert	35	35
Migration or Expulsion of Device	30	30
Patient Device Interaction Problem	29	29
Loss of or Failure to Bond	28	28
Material Separation	28	28
Malposition of Device	27	27
Migration	26	26
Incomplete or Inadequate Connection	22	22
Noise, Audible	22	22
Unintended Movement	21	21
Material Twisted/Bent	21	21
Device Contamination with Chemical or Other Material	21	21
Device-Device Incompatibility	17	17
Material Integrity Problem	16	16
Patient-Device Incompatibility	16	16
Device Markings/Labelling Problem	14	14
Physical Resistance/Sticking	14	14
Device Reprocessing Problem	12	12
Corroded	10	10
Fitting Problem	10	10
Use of Device Problem	10	10
Mechanics Altered	10	10
Contamination /Decontamination Problem	9	9
Degraded	9	9
Positioning Failure	8	8
Flaked	8	8
Inadequacy of Device Shape and/or Size	8	8
Improper or Incorrect Procedure or Method	7	7
Failure to Align	7	7
Osseointegration Problem	7	7
Packaging Problem	6	6
Tear, Rip or Hole in Device Packaging	6	6
Material Discolored	6	6
No Apparent Adverse Event	5	5
Separation Failure	5	5
Premature Separation	5	5
Failure to Disconnect	4	4
Positioning Problem	4	4
Misassembled	4	4
Device Damaged Prior to Use	4	4
Peeled/Delaminated	4	4
Off-Label Use	4	4
Difficult to Remove	3	3
Material Too Rigid or Stiff	3	3
Shipping Damage or Problem	3	3
Biocompatibility	3	3
Structural Problem	3	3
Delivered as Unsterile Product	3	3
Scratched Material	3	3
Manufacturing, Packaging or Shipping Problem	3	3
Material Split, Cut or Torn	3	3
Device Fell	2	2
Separation Problem	2	2
No Fail-Safe Mechanism	2	2
Device Damaged by Another Device	2	2
Device Packaging Compromised	2	2
Device Contaminated During Manufacture or Shipping	2	2
Activation, Positioning or Separation Problem	2	2
Nonstandard Device	2	2
Material Erosion	2	2
Failure to Charge	2	2
Partial Blockage	2	2
Failure to Osseointegrate	2	2
Device Slipped	2	2
Unexpected Therapeutic Results	2	2
Unsealed Device Packaging	2	2
Device Appears to Trigger Rejection	2	2
Material Puncture/Hole	1	1
Product Quality Problem	1	1
Difficult To Position	1	1
Device Difficult to Setup or Prepare	1	1
Suction Problem	1	1
Metal Shedding Debris	1	1
Defective Component	1	1
Solder Joint Fracture	1	1
Residue After Decontamination	1	1
Device Issue	1	1
Failure to Calibrate	1	1
Deformation Due to Compressive Stress	1	1

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
No Clinical Signs, Symptoms or Conditions	1937	1937
Pain	439	439
No Information	339	339
No Known Impact Or Consequence To Patient	229	229
Unspecified Infection	213	213
No Consequences Or Impact To Patient	201	201
No Code Available	192	192
No Patient Involvement	169	169
Failure of Implant	123	123
Insufficient Information	109	109
Ambulation Difficulties	101	101
Injury	86	86
Swelling/ Edema	66	66
Joint Laxity	61	61
Loss of Range of Motion	61	61
Joint Dislocation	56	56
Not Applicable	54	54
Bone Fracture(s)	53	53
Osteolysis	35	35
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available	35	35
Swelling	27	27
Synovitis	24	24
Foreign Body In Patient	21	21
Muscular Rigidity	16	16
Hypersensitivity/Allergic reaction	15	15
Inadequate Osseointegration	15	15
Inflammation	14	14
Fall	14	14
Discomfort	13	13
Adhesion(s)	12	12
Arthritis	10	10
Reaction	10	10
Post Operative Wound Infection	10	10
Joint Disorder	10	10
Limited Mobility Of The Implanted Joint	10	10
Scar Tissue	9	9
Device Embedded In Tissue or Plaque	7	7
Neck Stiffness	7	7
Death	7	7
Fatigue	6	6
Cellulitis	6	6
Hemorrhage/Bleeding	6	6
Cyst(s)	5	5
Implant Pain	5	5
Metal Related Pathology	5	5
Unspecified Tissue Injury	4	4
Fluid Discharge	4	4
Thrombosis/Thrombus	4	4
Damage to Ligament(s)	4	4
Numbness	4	4
Tissue Damage	3	3
Urinary Tract Infection	3	3
Burning Sensation	3	3
Joint Swelling	3	3
Osteopenia/ Osteoporosis	3	3
Hematoma	3	3
Laceration(s)	3	3
Ossification	3	3
Pulmonary Embolism	3	3
Autoimmune Reaction	3	3
Bacterial Infection	3	3
Unspecified Musculoskeletal problem	3	3
High Blood Pressure/ Hypertension	2	2
Low Blood Pressure/ Hypotension	2	2
Rash	2	2
Renal Failure	2	2
Patient Problem/Medical Problem	2	2
Sepsis	2	2
Scarring	1	1
Hip Fracture	1	1
Tissue Breakdown	1	1
Alteration In Body Temperature	1	1
Fibrosis	1	1
Vascular Dissection	1	1
Deformity/ Disfigurement	1	1
Non-union Bone Fracture	1	1
Perforation	1	1
Phlebitis	1	1
Muscle Weakness	1	1
Necrosis	1	1
Host-Tissue Reaction	1	1
Erosion	1	1
Calcium Deposits/Calcification	1	1
Aspiration/Inhalation	1	1
Autoimmune Disorder	1	1
Syncope	1	1
Edema	1	1
Embolism	1	1
Muscle/Tendon Damage	1	1
Hormonal Imbalance	1	1
Breast Discomfort/Pain	1	1
Subluxation	1	1
Unspecified Immune System Problem	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	DePuy Orthopaedics, Inc.	II	Mar-20-2018
6	Exactech, Inc.	II	Oct-04-2021
7	MicroPort Orthopedics Inc.	II	Nov-22-2022