TPLC - Total Product Life Cycle

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

Premarket Reviews
Manufacturer	Decision
DEPUY (IRELAND)
	SUBSTANTIALLY EQUIVALENT	1
DEPUY IRELAND UC
	SUBSTANTIALLY EQUIVALENT	1
HOWMEDICA OSTEONICS CORP. DBA STRYKER ORTHOPAEDICS
	SUBSTANTIALLY EQUIVALENT	2
LINK BIO CORP.
	SUBSTANTIALLY EQUIVALENT	1
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	1837	1837
Insufficient Information	588	588
Fracture	465	465
Loss of Osseointegration	247	247
Loosening of Implant Not Related to Bone-Ingrowth	224	224
Device Dislodged or Dislocated	195	195
Detachment of Device or Device Component	180	180
Unstable	172	172
Naturally Worn	142	142
Appropriate Term/Code Not Available	133	133
Break	88	88
Patient Device Interaction Problem	78	78
Device Appears to Trigger Rejection	75	75
Loose or Intermittent Connection	57	57
Degraded	54	54
Failure to Advance	49	49
Mechanical Problem	46	46
Migration	42	42
Patient-Device Incompatibility	41	41
Unintended Movement	39	39
Osseointegration Problem	39	39
Compatibility Problem	26	26
Separation Failure	21	21
Malposition of Device	20	20
Inadequacy of Device Shape and/or Size	18	18
Use of Device Problem	17	17
Improper or Incorrect Procedure or Method	17	17
Material Erosion	16	16
Packaging Problem	16	16
Mechanical Jam	15	15
Delivered as Unsterile Product	15	15
Tear, Rip or Hole in Device Packaging	14	14
Noise, Audible	14	14
No Apparent Adverse Event	12	12
Component Missing	12	12
Material Fragmentation	12	12
Loss of or Failure to Bond	11	11
Corroded	11	11
Migration or Expulsion of Device	11	11
Shipping Damage or Problem	11	11
Material Deformation	11	11
Manufacturing, Packaging or Shipping Problem	10	10
Crack	10	10
Connection Problem	9	9
Material Integrity Problem	9	9
Activation Failure	9	9
Failure to Osseointegrate	8	8
Unsealed Device Packaging	8	8
Off-Label Use	7	7
Positioning Failure	7	7

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
Unspecified Infection	1269	1269
Insufficient Information	717	717
Pain	511	511
Failure of Implant	480	480
Injury	360	360
Inadequate Osseointegration	223	223
No Clinical Signs, Symptoms or Conditions	203	203
Joint Laxity	187	187
No Code Available	174	174
Ambulation Difficulties	159	159
No Information	151	151
Joint Dislocation	147	147
Bone Fracture(s)	141	141
Fall	136	136
Cancer	118	118
Loss of Range of Motion	83	83
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available	79	79
No Known Impact Or Consequence To Patient	66	67
Scar Tissue	58	58
Unequal Limb Length	54	54
Patient Problem/Medical Problem	48	48
Inflammation	42	42
Swelling	42	42
Metal Related Pathology	39	39
Swelling/ Edema	39	39
Implant Pain	36	36
Joint Disorder	30	30
Limited Mobility Of The Implanted Joint	26	26
Unspecified Tissue Injury	25	25
Hematoma	23	23
Death	23	23
Adhesion(s)	22	22
Fluid Discharge	20	20
Wound Dehiscence	19	19
Bacterial Infection	19	19
Post Operative Wound Infection	19	19
Reaction	18	18
Foreign Body Reaction	17	17
Hypersensitivity/Allergic reaction	16	16
Muscle/Tendon Damage	14	14
Synovitis	14	14
Muscular Rigidity	14	14
No Consequences Or Impact To Patient	14	14
Hyperextension	12	12
Osteolysis	12	12
Ulcer	10	10
Post Traumatic Wound Infection	10	10
Osteopenia/ Osteoporosis	10	10
Necrosis	10	10
Damage to Ligament(s)	9	9

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