TPLC - Total Product Life Cycle

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Device	prosthesis, hip, semi-constrained, uncemented, metal / polymer, non-porous, calcium phosphate
Product Code	MEH
Regulation Number	888.3353
Device Class	2

Premarket Reviews
Manufacturer	Decision
CONFORMIS INC
	SUBSTANTIALLY EQUIVALENT	1
CONFORMIS INC.
	SUBSTANTIALLY EQUIVALENT	1
DEPUY IRELAND UC
	SUBSTANTIALLY EQUIVALENT	2
DEPUY ORTHOPAEDICS, INC.
	SUBSTANTIALLY EQUIVALENT	1
IMPLANTCAST GMBH
	SUBSTANTIALLY EQUIVALENT	1
IMPLANTCAST, GMBH
	SUBSTANTIALLY EQUIVALENT	1
NEXTSTEP ARTHROPEDIX
	SUBSTANTIALLY EQUIVALENT	1
ORTHO DEVELOPMENT CORP.
	SUBSTANTIALLY EQUIVALENT	1
SIGNATURE ORTHOPAEDICS PTY LTD
	SUBSTANTIALLY EQUIVALENT	1
SIGNATURE ORTHOPAEDICS PTY LTD.
	SUBSTANTIALLY EQUIVALENT	4
STRYKER
	SUBSTANTIALLY EQUIVALENT	1
STRYKER ORTHOPAEDICS
	SUBSTANTIALLY EQUIVALENT	1

Device Problems	MDRs with this Device Problem	Events in those MDRs
Adverse Event Without Identified Device or Use Problem	546	546
Device-Device Incompatibility	313	313
Insufficient Information	285	285
Device Dislodged or Dislocated	180	180
Appropriate Term/Code Not Available	152	152
Break	96	96
Osseointegration Problem	74	74
Fracture	61	61
Detachment of Device or Device Component	49	49
Degraded	49	49
Migration	38	38
Loosening of Implant Not Related to Bone-Ingrowth	37	37
Loose or Intermittent Connection	36	36
Material Erosion	35	35
Corroded	25	25
Device Appears to Trigger Rejection	23	23
Unstable	22	22
Device Contaminated During Manufacture or Shipping	22	22
Tear, Rip or Hole in Device Packaging	21	21
Loss of Osseointegration	14	14
Malposition of Device	14	14
Naturally Worn	13	13
Inadequacy of Device Shape and/or Size	8	8
Use of Device Problem	8	8
Failure to Cut	7	7
Noise, Audible	6	6
Inaccurate Information	6	6
Material Deformation	6	6
Mechanical Problem	6	6
Unintended Movement	6	6
Patient-Device Incompatibility	6	6
Migration or Expulsion of Device	5	5
Patient Device Interaction Problem	4	4
Difficult to Insert	4	4
Defective Device	4	4
Off-Label Use	4	4
Compatibility Problem	3	3
Difficult to Remove	3	3
Positioning Problem	3	3
Material Integrity Problem	3	3
Component Missing	3	3
Nonstandard Device	3	3
Device Damaged Prior to Use	3	3
No Apparent Adverse Event	3	3
Material Fragmentation	2	2
Manufacturing, Packaging or Shipping Problem	2	2
Mechanical Jam	2	2
Failure to Osseointegrate	2	2
Delivered as Unsterile Product	2	2
Calibration Problem	2	2

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
Unspecified Infection	344	344
Pain	324	324
Injury	214	214
Metal Related Pathology	151	151
Insufficient Information	144	144
Joint Dislocation	144	144
Inflammation	142	142
No Clinical Signs, Symptoms or Conditions	132	132
Foreign Body Reaction	131	131
Limb Fracture	111	111
Reaction	95	95
Inadequate Osseointegration	92	92
Failure of Implant	75	75
Fall	69	69
Bone Fracture(s)	68	68
Ambulation Difficulties	64	64
No Consequences Or Impact To Patient	49	49
No Known Impact Or Consequence To Patient	40	40
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available	37	37
Joint Laxity	33	33
Osteolysis	32	32
No Code Available	24	24
No Patient Involvement	21	21
Joint Disorder	16	16
Implant Pain	15	15
Local Reaction	14	14
Discomfort	13	13
Hip Fracture	13	13
Loss of Range of Motion	12	12
Bacterial Infection	12	12
Muscle/Tendon Damage	11	11
Physical Asymmetry	11	11
No Information	11	11
Swelling/ Edema	10	10
Necrosis	10	10
Unequal Limb Length	10	10
Hematoma	9	9
Wound Dehiscence	7	7
Unspecified Tissue Injury	6	6
Ossification	6	6
Host-Tissue Reaction	5	5
Tissue Damage	5	5
Heart Failure/Congestive Heart Failure	5	5
Hemorrhage/Bleeding	5	5
Deformity/ Disfigurement	5	5
Cyst(s)	4	4
Fluid Discharge	4	4
Foreign Body In Patient	4	4
Nerve Damage	4	4
Synovitis	3	3

Recalls
Manufacturer		Recall Class	Date Posted
1	Biomet, Inc.	II	Dec-17-2020
2	Corin Ltd	II	Sep-30-2021
3	Corin Ltd	II	Jun-11-2021
4	Corin Ltd	II	Mar-22-2021
5	Exactech, Inc.	II	Sep-09-2022
6	Signature Orthopaedics Europe Ltd	II	Mar-25-2020
7	Signature Orthopedics Pty Limited	II	May-28-2021
8	Waldemar Link GmbH & Co. KG (Mfg Site)	II	Jan-11-2019