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
DEPUY ORTHOPAEDICS, INC.
	SUBSTANTIALLY EQUIVALENT	1
EXACTECH, INC.
	SUBSTANTIALLY EQUIVALENT	1
IMPLANTCAST GMBH
	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	6
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	864	1413
Device-Device Incompatibility	370	372
Insufficient Information	220	222
Device Dislodged or Dislocated	190	194
Osseointegration Problem	132	671
Appropriate Term/Code Not Available	115	115
Fracture	70	589
Device Appears to Trigger Rejection	60	60
Migration	60	578
Break	58	59
Detachment of Device or Device Component	55	56
Loosening of Implant Not Related to Bone-Ingrowth	52	53
Device Markings/Labelling Problem	48	48
Naturally Worn	43	560
Degraded	41	45
Material Erosion	36	556
Tear, Rip or Hole in Device Packaging	31	31
Device Contaminated During Manufacture or Shipping	29	29
Corroded	23	23
Unstable	23	23
Loss of Osseointegration	19	20
Loose or Intermittent Connection	13	13
Malposition of Device	13	530
Use of Device Problem	10	10
Noise, Audible	7	7
Inadequacy of Device Shape and/or Size	7	7
Failure to Cut	7	7
Inaccurate Information	6	7
Positioning Problem	6	6
No Apparent Adverse Event	6	6
Patient-Device Incompatibility	5	5
Material Integrity Problem	5	5
Off-Label Use	5	5
Difficult to Insert	5	5
Nonstandard Device	4	5
Mechanical Problem	4	4
Material Deformation	4	4
Failure to Osseointegrate	4	4
Patient Device Interaction Problem	4	4
Difficult to Remove	4	4
Defective Device	4	4
Material Fragmentation	3	3
Component Missing	3	3
Device Damaged Prior to Use	3	3
Difficult to Open or Remove Packaging Material	3	3
Manufacturing, Packaging or Shipping Problem	3	3
Compatibility Problem	3	3
Improper or Incorrect Procedure or Method	3	542
Unintended Movement	3	3
Material Twisted/Bent	2	2

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
Unspecified Infection	455	998
Pain	394	941
Insufficient Information	235	777
No Clinical Signs, Symptoms or Conditions	224	225
Limb Fracture	202	202
Metal Related Pathology	181	707
Joint Dislocation	175	715
Foreign Body Reaction	163	169
Inadequate Osseointegration	146	147
Fall	111	113
Inflammation	108	108
Ambulation Difficulties	89	93
Failure of Implant	75	76
Bone Fracture(s)	71	75
Joint Laxity	64	581
Injury	58	58
Reaction	48	48
Osteolysis	47	587
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available	44	47
Implant Pain	35	35
Discomfort	23	27
Loss of Range of Motion	18	20
No Known Impact Or Consequence To Patient	18	18
Unequal Limb Length	17	556
No Patient Involvement	17	17
Swelling/ Edema	16	19
Bacterial Infection	15	15
Hip Fracture	14	14
Muscle/Tendon Damage	14	16
Local Reaction	14	36
Physical Asymmetry	14	15
No Code Available	13	13
Necrosis	12	531
Hematoma	9	10
Cyst(s)	8	10
Wound Dehiscence	8	9
Fluid Discharge	8	8
Deformity/ Disfigurement	7	548
No Information	7	7
Hemorrhage/Bleeding	6	6
Unspecified Tissue Injury	6	9
Ossification	6	524
Hypersensitivity/Allergic reaction	6	9
Synovitis	5	522
No Consequences Or Impact To Patient	5	5
Tissue Damage	5	5
Arthralgia	5	522
Heart Failure/Congestive Heart Failure	5	5
Joint Disorder	5	5
Foreign Body In Patient	5	5

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	Theken Companies LLC	II	Oct-21-2025