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
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
STRYKER ORTHOPAEDICS
	SUBSTANTIALLY EQUIVALENT	1

Device Problems	MDRs with this Device Problem	Events in those MDRs
Adverse Event Without Identified Device or Use Problem	594	594
Device-Device Incompatibility	321	321
Insufficient Information	192	192
Device Dislodged or Dislocated	136	136
Appropriate Term/Code Not Available	116	116
Osseointegration Problem	83	83
Break	55	55
Fracture	53	53
Detachment of Device or Device Component	47	47
Loosening of Implant Not Related to Bone-Ingrowth	38	38
Migration	37	37
Degraded	34	34
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
Unstable	17	17
Naturally Worn	16	16
Loose or Intermittent Connection	13	13
Loss of Osseointegration	11	11
Malposition of Device	9	9
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
Difficult to Insert	4	4
Patient Device Interaction Problem	4	4
Defective Device	4	4
Patient-Device Incompatibility	4	4
Off-Label Use	4	4
Mechanical Problem	4	4
Component Missing	3	3
Failure to Osseointegrate	3	3
Material Integrity Problem	3	3
Material Deformation	3	3
No Apparent Adverse Event	3	3
Unintended Movement	3	3
Device Damaged Prior to Use	3	3
Compatibility Problem	3	3
Difficult to Remove	2	2
Material Fragmentation	2	2
Positioning Problem	2	2
Manufacturing, Packaging or Shipping Problem	2	2
Nonstandard Device	2	2
Difficult to Open or Remove Packaging Material	2	2
Incomplete or Missing Packaging	2	2
Migration or Expulsion of Device	2	2
Scratched Material	1	1

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
Unspecified Infection	335	335
Pain	298	298
Insufficient Information	155	155
Metal Related Pathology	151	151
No Clinical Signs, Symptoms or Conditions	139	139
Foreign Body Reaction	131	131
Limb Fracture	130	130
Joint Dislocation	125	125
Inflammation	102	102
Inadequate Osseointegration	95	95
Fall	75	75
Failure of Implant	70	70
Bone Fracture(s)	65	65
Ambulation Difficulties	61	61
Injury	58	58
Reaction	48	48
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available	37	37
Joint Laxity	35	35
Osteolysis	35	35
Implant Pain	18	18
No Known Impact Or Consequence To Patient	18	18
No Patient Involvement	17	17
Bacterial Infection	14	14
Loss of Range of Motion	14	14
Swelling/ Edema	13	13
No Code Available	13	13
Local Reaction	13	13
Hip Fracture	13	13
Discomfort	12	12
Physical Asymmetry	11	11
Muscle/Tendon Damage	11	11
Unequal Limb Length	11	11
Necrosis	10	10
Hematoma	8	8
No Information	7	7
Wound Dehiscence	7	7
Unspecified Tissue Injury	6	6
Tissue Damage	5	5
Joint Disorder	5	5
Heart Failure/Congestive Heart Failure	5	5
No Consequences Or Impact To Patient	5	5
Cyst(s)	5	5
Ossification	5	5
Deformity/ Disfigurement	5	5
Host-Tissue Reaction	4	4
Fluid Discharge	4	4
Nerve Damage	4	4
Hemorrhage/Bleeding	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