TPLC - Total Product Life Cycle

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Device	prosthesis, hip, hemi-, femoral, metal
Regulation Description	Hip joint femoral (hemi-hip) metallic cemented or uncemented prosthesis.
Product Code	KWL
Regulation Number	888.3360
Device Class	2

Premarket Reviews
Manufacturer	Decision
BIOCOMPOSITES LTD.
	SUBSTANTIALLY EQUIVALENT	1
HERAEUS MEDICAL GMBH
	SUBSTANTIALLY EQUIVALENT	1
HOWMEDICA OSTEONICS CORP., DBA STRYKER ORTHOPAEDICS
	SUBSTANTIALLY EQUIVALENT	1
OSTEOREMEDIES, LLC
	SUBSTANTIALLY EQUIVALENT	2
TECRES S.P.A.
	SUBSTANTIALLY EQUIVALENT	1

Device Problems	MDRs with this Device Problem	Events in those MDRs
Adverse Event Without Identified Device or Use Problem	250	250
Device-Device Incompatibility	193	193
Biocompatibility	115	115
Material Twisted/Bent	110	110
Break	105	105
Loss of Osseointegration	94	94
Scratched Material	75	75
Device Dislodged or Dislocated	54	54
Insufficient Information	47	47
Naturally Worn	35	35
Fitting Problem	30	30
Loose or Intermittent Connection	30	30
Appropriate Term/Code Not Available	26	26
Physical Resistance/Sticking	24	24
Material Deformation	21	21
Fracture	20	20
Migration	18	18
Device Contaminated During Manufacture or Shipping	16	16
Nonstandard Device	14	14
Corroded	13	13
Tear, Rip or Hole in Device Packaging	13	13
Osseointegration Problem	12	12
Degraded	12	12
Detachment of Device or Device Component	10	10
Packaging Problem	10	10
Mechanical Jam	9	9
Inadequacy of Device Shape and/or Size	9	9
Entrapment of Device	7	7
Computer System Security Problem	7	7
Patient-Device Incompatibility	7	7
Material Integrity Problem	7	7
Difficult to Remove	7	7
Patient Device Interaction Problem	7	7
Malposition of Device	6	6
Connection Problem	6	6
Difficult to Insert	4	4
Loosening of Implant Not Related to Bone-Ingrowth	4	4
Defective Device	4	4
Compatibility Problem	4	4
Unstable	4	4
Use of Device Problem	3	3
Failure to Osseointegrate	3	3
Material Fragmentation	3	3
Unintended Movement	3	3
Crack	3	3
Migration or Expulsion of Device	3	3
Mechanical Problem	3	3
Loss of or Failure to Bond	3	3
Material Discolored	2	2
No Apparent Adverse Event	2	2

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
No Consequences Or Impact To Patient	320	320
No Code Available	226	226
Pain	167	167
Metal Related Pathology	122	122
Insufficient Information	114	114
Unspecified Infection	97	97
Not Applicable	60	60
Injury	49	49
Test Result	47	47
Joint Dislocation	46	46
Bone Fracture(s)	45	45
Inadequate Osseointegration	42	42
No Clinical Signs, Symptoms or Conditions	36	36
Osteolysis	33	33
Failure of Implant	33	33
Foreign Body Reaction	21	21
Discomfort	21	21
Tissue Damage	21	21
Loss of Range of Motion	18	18
Limited Mobility Of The Implanted Joint	15	15
Infiltration into Tissue	15	15
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available	15	15
Inflammation	14	14
Ambulation Difficulties	13	13
Fall	12	12
Leiomyosarcoma	11	11
Arthralgia	11	11
No Known Impact Or Consequence To Patient	11	11
No Information	8	8
Edema	8	8
Necrosis	7	7
Hematoma	6	6
Hypersensitivity/Allergic reaction	6	6
Toxicity	5	5
Swelling/ Edema	5	5
Synovitis	5	5
Implant Pain	5	5
Hip Fracture	5	5
Joint Laxity	4	4
Cyst(s)	4	4
No Patient Involvement	4	4
Blood Loss	4	4
Thrombosis	4	4
Swelling	4	4
Muscle/Tendon Damage	3	3
Bacterial Infection	3	3
Limb Fracture	3	3
Distress	3	3
Ossification	3	3
Solid Tumour	3	3

Recalls
Manufacturer		Recall Class	Date Posted
1	Howmedica Osteonics Corp.	II	Jul-16-2024