TPLC - Total Product Life Cycle

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Device	prosthesis, hip, semi-constrained, uncemented, metal / polymer, non-porous, calcium phosphate
Regulation Description	Hip joint metal/ceramic/polymer semi-constrained cemented or nonporous uncemented prosthesis.
Product Code	MEH
Regulation Number	888.3353
Device Class	2

Premarket Reviews
Manufacturer	Decision
CONFORMIS, INC.
	SUBSTANTIALLY EQUIVALENT	2
CORIN U.S.A. LIMITED
	SUBSTANTIALLY EQUIVALENT	1
DEPUY IRELAND UC
	SUBSTANTIALLY EQUIVALENT	2
EXACTECH, INC.
	SUBSTANTIALLY EQUIVALENT	1
MEDACTA INTERNATIONAL S.A.
	SUBSTANTIALLY EQUIVALENT	1
NEXTSTEP ARTHROPEDIX
	SUBSTANTIALLY EQUIVALENT	1
ORTHO DEVELOPMENT CORP.
	SUBSTANTIALLY EQUIVALENT	2
SIGNATURE ORTHOPAEDICS PTY, LTD.
	SUBSTANTIALLY EQUIVALENT	5
STRYKER
	SUBSTANTIALLY EQUIVALENT	1
STRYKER ORTHOPAEDICS
	SUBSTANTIALLY EQUIVALENT	1
UNITED ORTHOPEDIC CORPORATION
	SUBSTANTIALLY EQUIVALENT	1
WALDEMAR LINK GMBH & CO. KG
	SUBSTANTIALLY EQUIVALENT	1

Device Problems	MDRs with this Device Problem	Events in those MDRs
Adverse Event Without Identified Device or Use Problem	785	1333
Device-Device Incompatibility	288	290
Device Dislodged or Dislocated	138	141
Insufficient Information	134	135
Osseointegration Problem	125	664
Appropriate Term/Code Not Available	77	77
Device Appears to Trigger Rejection	58	58
Migration	53	571
Fracture	52	571
Device Markings/Labelling Problem	48	48
Detachment of Device or Device Component	45	46
Loosening of Implant Not Related to Bone-Ingrowth	41	42
Break	39	39
Naturally Worn	38	555
Degraded	33	37
Material Erosion	29	549
Tear, Rip or Hole in Device Packaging	26	26
Device Contaminated During Manufacture or Shipping	23	23
Corroded	19	19
Unstable	19	19
Loss of Osseointegration	16	17
Use of Device Problem	10	10
Malposition of Device	10	527
Loose or Intermittent Connection	8	8
Failure to Cut	7	7
Inaccurate Information	6	7
Noise, Audible	5	5
Material Integrity Problem	5	5
Positioning Problem	5	5
Difficult to Insert	5	5
Off-Label Use	5	5
Patient Device Interaction Problem	4	4
Patient-Device Incompatibility	4	4
Failure to Osseointegrate	4	4
Mechanical Problem	4	4
Inadequacy of Device Shape and/or Size	4	4
Nonstandard Device	4	5
No Apparent Adverse Event	4	4
Defective Device	3	3
Difficult to Remove	3	3
Improper or Incorrect Procedure or Method	3	542
Device Damaged Prior to Use	3	3
Material Deformation	3	3
Difficult to Open or Remove Packaging Material	3	3
Unintended Movement	2	2
Difficult to Advance	2	2
Loss of or Failure to Bond	2	2
Delivered as Unsterile Product	2	2
Crack	2	2
Incomplete or Missing Packaging	2	2

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
Unspecified Infection	392	934
Pain	344	889
Insufficient Information	219	761
No Clinical Signs, Symptoms or Conditions	210	211
Limb Fracture	190	190
Metal Related Pathology	174	700
Joint Dislocation	136	676
Inadequate Osseointegration	135	136
Foreign Body Reaction	129	135
Fall	100	102
Ambulation Difficulties	69	72
Joint Laxity	57	574
Bone Fracture(s)	51	54
Failure of Implant	50	51
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available	43	46
Osteolysis	41	581
Implant Pain	29	29
Discomfort	20	23
Inflammation	18	18
Swelling/ Edema	16	19
Unequal Limb Length	16	555
Loss of Range of Motion	15	17
Physical Asymmetry	14	15
Muscle/Tendon Damage	14	16
Hip Fracture	13	13
Necrosis	11	530
Bacterial Infection	10	10
Fluid Discharge	8	8
Wound Dehiscence	8	9
Cyst(s)	7	9
Hematoma	7	8
Deformity/ Disfigurement	7	548
Unspecified Tissue Injury	6	9
Hemorrhage/Bleeding	6	6
Local Reaction	6	28
Hypersensitivity/Allergic reaction	6	9
Heart Failure/Congestive Heart Failure	5	5
Arthralgia	5	522
Ossification	5	523
Synovitis	4	521
Nerve Damage	4	4
Cellulitis	4	4
Numbness	4	4
Impaired Healing	4	4
Tissue Damage	3	3
Abscess	3	3
Muscular Rigidity	3	5
Erythema	3	3
Distress	3	5
Thrombosis/Thrombus	3	3

Recalls
Manufacturer		Recall Class	Date Posted
1	Corin Ltd	II	Sep-30-2021
2	Corin Ltd	II	Jun-11-2021
3	Corin Ltd	II	Mar-22-2021
4	Exactech, Inc.	II	Sep-09-2022
5	Signature Orthopedics Pty Limited	II	May-28-2021
6	Theken Companies LLC	II	Oct-21-2025