TPLC - Total Product Life Cycle

show TPLC since

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
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
1. K211703 Insignia Hip Stem
STRYKER ORTHOPAEDICS
	SUBSTANTIALLY EQUIVALENT	1
1. K211703 Insignia Hip Stem

Device Problems	MDRs with this Device Problem	Events in those MDRs
Adverse Event Without Identified Device or Use Problem	647	647
Device-Device Incompatibility	323	323
Insufficient Information	192	192
Device Dislodged or Dislocated	159	159
Appropriate Term/Code Not Available	116	116
Osseointegration Problem	90	90
Fracture	58	58
Break	55	55
Detachment of Device or Device Component	48	48
Migration	39	39
Loosening of Implant Not Related to Bone-Ingrowth	38	38
Degraded	35	35
Device Appears to Trigger Rejection	31	31
Material Erosion	31	31
Device Contaminated During Manufacture or Shipping	23	23
Tear, Rip or Hole in Device Packaging	21	21
Corroded	20	20
Naturally Worn	18	18
Unstable	17	17
Loose or Intermittent Connection	13	13
Loss of Osseointegration	12	12
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
Inaccurate Information	6	6
Noise, Audible	6	6
Patient-Device Incompatibility	5	5
Difficult to Insert	4	4
Off-Label Use	4	4
Mechanical Problem	4	4
Patient Device Interaction Problem	4	4
Defective Device	4	4
Compatibility Problem	3	3
Device Damaged Prior to Use	3	3
Failure to Osseointegrate	3	3
No Apparent Adverse Event	3	3
Unintended Movement	3	3
Component Missing	3	3
Material Integrity Problem	3	3
Material Deformation	3	3
Manufacturing, Packaging or Shipping Problem	2	2
Difficult to Remove	2	2
Nonstandard Device	2	2
Material Fragmentation	2	2
Positioning Problem	2	2
Incomplete or Missing Packaging	2	2
Difficult to Open or Remove Packaging Material	2	2
Migration or Expulsion of Device	2	2
Difficult or Delayed Positioning	1	1

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
Unspecified Infection	360	360
Pain	320	320
Insufficient Information	180	180
Metal Related Pathology	152	152
Joint Dislocation	148	148
No Clinical Signs, Symptoms or Conditions	143	143
Limb Fracture	135	135
Foreign Body Reaction	133	133
Inflammation	102	102
Inadequate Osseointegration	101	101
Ambulation Difficulties	88	88
Fall	75	75
Failure of Implant	70	70
Bone Fracture(s)	65	65
Injury	58	58
Reaction	48	48
Joint Laxity	38	38
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available	37	37
Osteolysis	36	36
Implant Pain	19	19
No Known Impact Or Consequence To Patient	18	18
No Patient Involvement	17	17
Discomfort	15	15
Loss of Range of Motion	14	14
Bacterial Infection	14	14
Muscle/Tendon Damage	13	13
Swelling/ Edema	13	13
Hip Fracture	13	13
Local Reaction	13	13
No Code Available	13	13
Unequal Limb Length	11	11
Physical Asymmetry	11	11
Necrosis	10	10
Hematoma	8	8
Wound Dehiscence	7	7
No Information	7	7
Unspecified Tissue Injury	6	6
Ossification	5	5
Cyst(s)	5	5
Heart Failure/Congestive Heart Failure	5	5
Tissue Damage	5	5
No Consequences Or Impact To Patient	5	5
Joint Disorder	5	5
Deformity/ Disfigurement	5	5
Fluid Discharge	4	4
Nerve Damage	4	4
Foreign Body In Patient	4	4
Erythema	4	4
Hypersensitivity/Allergic reaction	4	4
Host-Tissue Reaction	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