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 UC
	SUBSTANTIALLY EQUIVALENT	1
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	1836	1836
Insufficient Information	406	406
Fracture	403	403
Loosening of Implant Not Related to Bone-Ingrowth	216	216
Loss of Osseointegration	210	210
Device Dislodged or Dislocated	165	165
Detachment of Device or Device Component	158	158
Unstable	145	145
Naturally Worn	122	122
Appropriate Term/Code Not Available	97	97
Device Appears to Trigger Rejection	85	85
Patient Device Interaction Problem	66	66
Migration	54	54
Break	52	52
Loose or Intermittent Connection	47	47
Failure to Advance	43	43
Patient-Device Incompatibility	41	41
Degraded	39	39
Unintended Movement	35	35
Osseointegration Problem	32	32
Mechanical Problem	32	32
Separation Failure	21	21
Inadequacy of Device Shape and/or Size	17	17
Improper or Incorrect Procedure or Method	16	16
Use of Device Problem	15	15
Malposition of Device	13	13
Loss of or Failure to Bond	12	12
Compatibility Problem	12	12
Tear, Rip or Hole in Device Packaging	12	12
Packaging Problem	12	12
Material Erosion	12	12
Noise, Audible	11	11
No Apparent Adverse Event	11	11
Material Fragmentation	10	10
Shipping Damage or Problem	10	10
Corroded	10	10
Activation Failure	9	9
Connection Problem	9	9
Unsealed Device Packaging	8	8
Migration or Expulsion of Device	8	8
Mechanical Jam	8	8
Delivered as Unsterile Product	8	8
Off-Label Use	7	7
Manufacturing, Packaging or Shipping Problem	7	7
Failure to Osseointegrate	7	7
Expiration Date Error	6	6
Positioning Failure	6	6
Component Missing	6	6
Material Separation	5	5
Material Integrity Problem	4	4

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
Unspecified Infection	1161	1161
Insufficient Information	750	750
Failure of Implant	420	420
Pain	411	411
No Clinical Signs, Symptoms or Conditions	207	207
Joint Laxity	207	207
Inadequate Osseointegration	197	197
Ambulation Difficulties	165	165
Injury	152	152
Joint Dislocation	148	148
Fall	127	127
Bone Fracture(s)	120	120
No Code Available	96	96
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available	84	84
Loss of Range of Motion	67	67
Cancer	61	61
No Information	59	59
Scar Tissue	56	56
Unequal Limb Length	51	51
Implant Pain	49	49
Swelling/ Edema	41	41
Metal Related Pathology	40	40
Inflammation	39	39
No Known Impact Or Consequence To Patient	36	36
Unspecified Tissue Injury	27	27
Adhesion(s)	23	23
Fluid Discharge	21	21
Hematoma	19	19
Wound Dehiscence	19	19
Muscle/Tendon Damage	16	16
Hypersensitivity/Allergic reaction	16	16
Foreign Body Reaction	15	15
Bacterial Infection	14	14
Muscular Rigidity	14	14
Osteopenia/ Osteoporosis	13	13
Joint Disorder	12	12
Synovitis	12	12
Hyperextension	12	12
Osteolysis	12	12
Necrosis	10	10
Ulcer	10	10
Reaction	10	10
Post Operative Wound Infection	10	10
Post Traumatic Wound Infection	10	10
Patient Problem/Medical Problem	10	10
Swelling	10	10
Ossification	9	9
Discomfort	9	9
Damage to Ligament(s)	9	9
Joint Contracture	8	8

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