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	2
MEDACTA INTERNATIONAL SA
	SUBSTANTIALLY EQUIVALENT	1
MICROPORT ORTHOPEDICS INC.
	SUBSTANTIALLY EQUIVALENT	2
ONKOS SURGICAL
	SUBSTANTIALLY EQUIVALENT	1
STRYKER
	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	1967	2072
Fracture	446	481
Insufficient Information	430	430
Loosening of Implant Not Related to Bone-Ingrowth	233	331
Loss of Osseointegration	216	216
Device Dislodged or Dislocated	169	204
Detachment of Device or Device Component	169	169
Unstable	149	149
Naturally Worn	122	122
Appropriate Term/Code Not Available	97	97
Device Appears to Trigger Rejection	91	91
Patient Device Interaction Problem	67	67
Migration	55	55
Break	54	54
Loose or Intermittent Connection	47	47
Patient-Device Incompatibility	45	45
Failure to Advance	43	43
Osseointegration Problem	40	40
Degraded	40	40
Unintended Movement	37	37
Mechanical Problem	34	34
Separation Failure	21	21
Inadequacy of Device Shape and/or Size	17	17
Use of Device Problem	17	17
Improper or Incorrect Procedure or Method	16	16
Malposition of Device	13	13
Material Erosion	13	55
Loss of or Failure to Bond	13	13
Compatibility Problem	12	12
Tear, Rip or Hole in Device Packaging	12	12
Packaging Problem	12	12
Noise, Audible	11	11
No Apparent Adverse Event	11	11
Shipping Damage or Problem	10	10
Material Fragmentation	10	10
Corroded	10	10
Connection Problem	9	9
Migration or Expulsion of Device	9	9
Activation Failure	9	9
Biocompatibility	8	8
Unsealed Device Packaging	8	8
Delivered as Unsterile Product	8	8
Failure to Osseointegrate	8	8
Mechanical Jam	8	8
Off-Label Use	7	7
Positioning Failure	7	7
Manufacturing, Packaging or Shipping Problem	7	7
Component Missing	7	7
Expiration Date Error	6	6
Material Separation	5	5

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
Unspecified Infection	1195	1300
Insufficient Information	782	852
Failure of Implant	465	465
Pain	440	440
Joint Laxity	226	324
No Clinical Signs, Symptoms or Conditions	215	215
Inadequate Osseointegration	210	210
Ambulation Difficulties	172	172
Injury	152	152
Joint Dislocation	152	152
Fall	130	130
Bone Fracture(s)	125	230
No Code Available	96	96
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available	88	88
Loss of Range of Motion	81	158
Cancer	61	61
No Information	59	59
Scar Tissue	56	56
Implant Pain	52	52
Unequal Limb Length	51	51
Swelling/ Edema	49	49
Metal Related Pathology	41	41
Inflammation	39	39
No Known Impact Or Consequence To Patient	36	36
Unspecified Tissue Injury	27	27
Adhesion(s)	23	23
Fluid Discharge	23	23
Hematoma	22	64
Hypersensitivity/Allergic reaction	21	21
Wound Dehiscence	21	21
Muscle/Tendon Damage	19	19
Hyperextension	17	17
Osteolysis	17	101
Foreign Body Reaction	15	15
Muscular Rigidity	14	14
Bacterial Infection	14	14
Osteopenia/ Osteoporosis	13	13
Joint Contracture	12	12
Synovitis	12	12
Joint Disorder	12	12
Necrosis	10	10
Post Traumatic Wound Infection	10	10
Post Operative Wound Infection	10	10
Swelling	10	10
Reaction	10	10
Patient Problem/Medical Problem	10	10
Ulcer	10	10
Damage to Ligament(s)	9	9
Ossification	9	9
Discomfort	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