TPLC - Total Product Life Cycle

• Device: prosthesis, knee, patellofemorotibial, semi-constrained, metal/polymer, mobile bearing
• Definition: This type of device is designed to allow for motion between the plastic bearing and metal baseplate components of a knee prosthesis. It is intended to replace a knee joint in order to relieve pain and restore knee function, for indications such as osteoarthritis, inflammatory arthritis, traumatic arthritis, and revision of failed knee prostheses.
• Product Code: NJL
• Device Class: 3

Premarket Approvals (PMA)
2021	2022	2023	2024	2025	2026
18	30	17	23	23	10

MDR Year	MDR Reports	MDR Events
2021	2643	2667
2022	2319	2360
2023	1593	1618
2024	1236	1244
2025	1102	1102
2026	407	407

Device Problems	MDRs with this Device Problem	Events in those MDRs
Adverse Event Without Identified Device or Use Problem	6846	6906
Loss of or Failure to Bond	1079	1098
Naturally Worn	443	448
Osseointegration Problem	218	221
Migration	218	225
Unintended Movement	133	134
Device Dislodged or Dislocated	123	126
Device Contaminated During Manufacture or Shipping	97	97
Fracture	88	88
Difficult to Open or Remove Packaging Material	69	69
Use of Device Problem	53	53
Noise, Audible	49	52
Off-Label Use	48	48
Appropriate Device Problem Term/Code Not Available	38	39
No Apparent Adverse Event	38	38
Tear, Rip or Hole in Device Packaging	37	37
Difficult to Insert	32	32
Improper or Incorrect Procedure or Method	17	17
Insufficient Device Problem Information	16	16
Patient Device Interaction Problem	15	15
Break	12	13
Device Damaged Prior to Use	11	11
Patient-Device Incompatibility	10	12
Difficult to Advance	10	10
Device-Device Incompatibility	9	10
Incorrect Measurement	7	9
Expiration Date Error	7	7
Inaccurate Information	5	6
Inadequacy of Device Shape and/or Size	4	4
Loosening of Implant Not Related to Bone-Ingrowth	4	5
Unstable	3	3
Incomplete or Missing Packaging	3	3
Illegible Information	3	3
Corroded	3	3
Defective Device	2	2
Device Damaged Prior to Receipt by User	2	2
Loss of Osseointegration	2	2
Degraded	2	2
Manufacturing, Packaging or Shipping Problem	2	2
Computer Software Problem	2	2
Material Integrity Problem	1	1
Mechanical Jam	1	1
Missing Information	1	1
Nonstandard Device	1	1
Material Deformation	1	1
Entrapment of Device	1	1
Packaging Problem	1	1
Material Erosion	1	1
Detachment of Device or Device Component	1	1
Malposition of Device	1	1

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
Pain	2915	2974
Unspecified Infection	2260	2273
Joint Laxity	1979	2014
Insufficient Information	1161	1170
Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available	653	655
Swelling/ Edema	532	563
Adhesion(s)	506	513
Loss of Range of Motion	502	520
Muscular Rigidity	445	451
Fall	329	333
Unspecified Tissue Injury	252	259
No Clinical Signs, Symptoms or Conditions	240	243
Synovitis	221	228
Inadequate Osseointegration	219	223
Osteolysis	176	182
Ambulation or Postural Difficulties	156	176
Discomfort	147	155
Bone Fracture(s)	124	127
Wound Dehiscence	114	115
Inflammation	113	119
Joint Dislocation	102	105
Unspecified Musculoskeletal problem	90	92
Hemorrhage/Blood Loss/Bleeding	67	68
Foreign Body Reaction	64	65
Fluid Discharge	61	61
Thrombosis/Thrombus	58	58
Hypersensitivity/Allergic reaction	57	59
Joint Contracture	52	53
Fatigue	44	51
Erythema	44	44
Scar Tissue	42	44
Muscle/Tendon Damage	42	43
Hematoma	38	38
Pulmonary Embolism	37	37
Impaired Healing	35	35
Cyst(s)	35	35
Sepsis	30	31
Fibrosis	26	26
Necrosis	25	25
Extraskeletal ossification	24	24
Fever	23	23
Abscess	20	20
Nerve Damage	19	19
Post Operative Wound Infection	15	15
Cellulitis	14	14
Failure of Implant	12	16
Anemia	11	11
Low Blood Pressure/ Hypotension	10	10
Numbness	10	10
Physical Asymmetry	10	11

Recalls
Manufacturer		Recall Class	Date Posted
1	DePuy Orthopaedics, Inc.	II	Sep-01-2021
2	DePuy Orthopaedics, Inc.	II	Mar-29-2021