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	1
CONFORMIS INC.
	SUBSTANTIALLY EQUIVALENT	1
CORIN USA LIMITED
	SUBSTANTIALLY EQUIVALENT	1
DEPUY IRELAND UC
	SUBSTANTIALLY EQUIVALENT	2
DEPUY ORTHOPAEDICS, INC.
	SUBSTANTIALLY EQUIVALENT	1
EXACTECH, INC.
	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	2
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	672	672
Device-Device Incompatibility	335	335
Insufficient Information	193	193
Device Dislodged or Dislocated	166	166
Appropriate Term/Code Not Available	116	116
Osseointegration Problem	94	94
Fracture	58	58
Break	56	56
Detachment of Device or Device Component	50	50
Migration	39	39
Device Appears to Trigger Rejection	37	37
Loosening of Implant Not Related to Bone-Ingrowth	37	37
Degraded	35	35
Material Erosion	34	34
Device Contaminated During Manufacture or Shipping	24	24
Tear, Rip or Hole in Device Packaging	21	21
Corroded	20	20
Naturally Worn	20	20
Unstable	19	19
Loss of Osseointegration	16	16
Loose or Intermittent Connection	13	13
Malposition of Device	10	10
Use of Device Problem	9	9
Inadequacy of Device Shape and/or Size	7	7
Failure to Cut	7	7
Noise, Audible	6	6
Inaccurate Information	6	6
Patient-Device Incompatibility	5	5
Mechanical Problem	4	4
Patient Device Interaction Problem	4	4
Off-Label Use	4	4
Difficult to Insert	4	4
Defective Device	4	4
Compatibility Problem	3	3
Component Missing	3	3
Device Damaged Prior to Use	3	3
Failure to Osseointegrate	3	3
Material Integrity Problem	3	3
Unintended Movement	3	3
No Apparent Adverse Event	3	3
Material Deformation	3	3
Migration or Expulsion of Device	2	2
Incomplete or Missing Packaging	2	2
Difficult to Open or Remove Packaging Material	2	2
Nonstandard Device	2	2
Delivered as Unsterile Product	2	2
Manufacturing, Packaging or Shipping Problem	2	2
Positioning Problem	2	2
Material Fragmentation	2	2
Difficult to Remove	2	2

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
Unspecified Infection	373	373
Pain	328	328
Insufficient Information	185	185
Metal Related Pathology	156	156
Joint Dislocation	154	154
No Clinical Signs, Symptoms or Conditions	147	147
Limb Fracture	142	142
Foreign Body Reaction	141	141
Inadequate Osseointegration	109	109
Inflammation	102	102
Ambulation Difficulties	88	88
Fall	78	78
Failure of Implant	71	71
Bone Fracture(s)	66	66
Injury	58	58
Reaction	48	48
Joint Laxity	40	40
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available	38	38
Osteolysis	36	36
Implant Pain	21	21
No Known Impact Or Consequence To Patient	18	18
No Patient Involvement	17	17
Discomfort	16	16
Bacterial Infection	14	14
Loss of Range of Motion	14	14
Swelling/ Edema	13	13
No Code Available	13	13
Hip Fracture	13	13
Muscle/Tendon Damage	13	13
Local Reaction	13	13
Unequal Limb Length	12	12
Physical Asymmetry	11	11
Necrosis	10	10
Hematoma	9	9
No Information	7	7
Wound Dehiscence	7	7
Unspecified Tissue Injury	6	6
Joint Disorder	5	5
Tissue Damage	5	5
Cyst(s)	5	5
Heart Failure/Congestive Heart Failure	5	5
Fluid Discharge	5	5
Ossification	5	5
No Consequences Or Impact To Patient	5	5
Deformity/ Disfigurement	5	5
Host-Tissue Reaction	4	4
Hemorrhage/Bleeding	4	4
Nerve Damage	4	4
Erythema	4	4
Foreign Body In Patient	4	4

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