TPLC - Total Product Life Cycle

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Device	prosthesis, knee, femorotibial, constrained, cemented, metal/polymer
Regulation Description	Knee joint femorotibial metal/polymer constrained cemented prosthesis.
Product Code	KRO
Regulation Number	888.3510
Device Class	2

Premarket Reviews
Manufacturer	Decision
DEPUY IRELAND UC
	SUBSTANTIALLY EQUIVALENT	2
HOWMEDICA OSTEONICS CORP. DBA STRYKER ORTHOPAEDICS
	SUBSTANTIALLY EQUIVALENT	3
MEDACTA INTERNATIONAL SA
	SUBSTANTIALLY EQUIVALENT	1
MICROPORT ORTHOPEDICS INC.
	SUBSTANTIALLY EQUIVALENT	2
ONKOS SURGICAL
	SUBSTANTIALLY EQUIVALENT	1
STRYKER
	SUBSTANTIALLY EQUIVALENT	1
UNITED ORTHOPEDIC CORPORATION
	SUBSTANTIALLY EQUIVALENT	1
WALDEMAR LINK GMBH & CO. KG
	SUBSTANTIALLY EQUIVALENT	2
ZIMMER, INC.
	SUBSTANTIALLY EQUIVALENT	1

Device Problems	MDRs with this Device Problem	Events in those MDRs
Adverse Event Without Identified Device or Use Problem	2220	2887
Insufficient Information	472	472
Fracture	472	514
Loss of Osseointegration	261	261
Loosening of Implant Not Related to Bone-Ingrowth	260	901
Device Dislodged or Dislocated	185	227
Detachment of Device or Device Component	169	169
Unstable	159	159
Naturally Worn	128	128
Device Appears to Trigger Rejection	105	105
Appropriate Term/Code Not Available	100	100
Patient Device Interaction Problem	68	68
Patient-Device Incompatibility	64	64
Mechanical Problem	57	57
Migration	56	56
Break	54	54
Loose or Intermittent Connection	48	48
Degraded	47	47
Osseointegration Problem	46	72
Failure to Advance	44	44
Unintended Movement	37	37
Separation Failure	21	21
Improper or Incorrect Procedure or Method	17	17
Inadequacy of Device Shape and/or Size	17	17
Use of Device Problem	17	17
Malposition of Device	15	551
Material Erosion	15	614
Loss of or Failure to Bond	13	13
No Apparent Adverse Event	12	12
Tear, Rip or Hole in Device Packaging	12	12
Packaging Problem	12	12
Compatibility Problem	12	12
Noise, Audible	11	11
Corroded	10	10
Shipping Damage or Problem	10	10
Material Fragmentation	10	10
Migration or Expulsion of Device	9	9
Connection Problem	9	9
Activation Failure	9	9
Off-Label Use	8	8
Mechanical Jam	8	8
Unsealed Device Packaging	8	8
Delivered as Unsterile Product	8	8
Failure to Osseointegrate	8	8
Component Missing	7	7
Manufacturing, Packaging or Shipping Problem	7	7
Nonstandard Device	6	6
Positioning Failure	6	6
Expiration Date Error	6	6
Material Separation	5	5

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
Unspecified Infection	1319	1986
Insufficient Information	867	1509
Failure of Implant	507	507
Pain	495	521
Inadequate Osseointegration	262	262
Joint Laxity	251	918
No Clinical Signs, Symptoms or Conditions	221	221
Ambulation Difficulties	184	184
Joint Dislocation	167	703
Injury	152	152
Bone Fracture(s)	139	780
Fall	134	134
No Code Available	96	96
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available	94	94
Loss of Range of Motion	91	196
Cancer	61	61
Implant Pain	61	61
No Information	59	59
Scar Tissue	56	56
Unequal Limb Length	55	55
Swelling/ Edema	55	55
Metal Related Pathology	48	48
Inflammation	40	40
Unspecified Tissue Injury	39	39
No Known Impact Or Consequence To Patient	36	36
Adhesion(s)	33	33
Hematoma	30	93
Fluid Discharge	25	25
Wound Dehiscence	23	23
Muscle/Tendon Damage	22	22
Osteolysis	21	152
Hypersensitivity/Allergic reaction	19	19
Muscular Rigidity	19	19
Bacterial Infection	18	18
Hyperextension	17	17
Foreign Body Reaction	15	15
Synovitis	14	14
Osteopenia/ Osteoporosis	13	13
Ossification	12	12
Joint Contracture	12	12
Joint Disorder	12	12
Ulcer	10	10
Post Operative Wound Infection	10	10
Post Traumatic Wound Infection	10	10
Necrosis	10	10
Swelling	10	10
Reaction	10	10
Patient Problem/Medical Problem	10	10
Peripheral Nervous Injury	10	10
Hemorrhage/Bleeding	9	9

Recalls
Manufacturer		Recall Class	Date Posted
1	DePuy Orthopaedics, Inc.	II	Mar-17-2023
2	Linkbio Corp.	II	May-04-2023
3	Onkos Surgical, Inc.	II	May-29-2025
4	Onkos Surgical, Inc.	II	May-28-2025
5	United Orthopedic Corporation	II	Feb-29-2024
6	Uoc Usa Inc	II	Oct-14-2021
7	Waldemar Link GmbH & Co. KG (Mfg Site)	II	Jun-30-2023