TPLC - Total Product Life Cycle

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Device	prosthesis, hip, hemi-, femoral, metal
Product Code	KWL
Regulation Number	888.3360
Device Class	2

Premarket Reviews
Manufacturer	Decision
HERAEUS MEDICAL GMBH
	SUBSTANTIALLY EQUIVALENT	1
HOWMEDICA OSTEONICS CORP., DBA STRYKER ORTHOPAEDICS
	SUBSTANTIALLY EQUIVALENT	1
OSTEOREMEDIES, LLC
	SUBSTANTIALLY EQUIVALENT	2

Device Problems	MDRs with this Device Problem	Events in those MDRs
Adverse Event Without Identified Device or Use Problem	241	241
Device-Device Incompatibility	193	193
Material Twisted/Bent	110	110
Break	104	104
Biocompatibility	101	101
Loss of Osseointegration	94	94
Scratched Material	75	75
Device Dislodged or Dislocated	50	50
Insufficient Information	46	46
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
Migration	18	18
Device Contaminated During Manufacture or Shipping	16	16
Fracture	16	16
Nonstandard Device	14	14
Tear, Rip or Hole in Device Packaging	13	13
Osseointegration Problem	12	12
Degraded	12	12
Corroded	11	11
Packaging Problem	10	10
Mechanical Jam	9	9
Inadequacy of Device Shape and/or Size	9	9
Detachment of Device or Device Component	8	8
Entrapment of Device	7	7
Computer System Security Problem	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
Patient-Device Incompatibility	5	5
Compatibility Problem	4	4
Defective Device	4	4
Difficult to Insert	4	4
Failure to Osseointegrate	3	3
Use of Device Problem	3	3
Material Fragmentation	3	3
Unintended Movement	3	3
Crack	3	3
Migration or Expulsion of Device	3	3
Mechanical Problem	3	3
Unstable	3	3
Material Discolored	2	2
Loosening of Implant Not Related to Bone-Ingrowth	2	2
No Apparent Adverse Event	2	2
Unsealed Device Packaging	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	156	156
Insufficient Information	112	112
Metal Related Pathology	108	108
Unspecified Infection	91	91
Not Applicable	60	60
Injury	49	49
Test Result	47	47
Bone Fracture(s)	45	45
Inadequate Osseointegration	42	42
Joint Dislocation	39	39
No Clinical Signs, Symptoms or Conditions	35	35
Osteolysis	31	31
Failure of Implant	29	29
Tissue Damage	21	21
Discomfort	20	20
Foreign Body Reaction	20	20
Loss of Range of Motion	18	18
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available	15	15
Infiltration into Tissue	15	15
Limited Mobility Of The Implanted Joint	15	15
Inflammation	13	13
Fall	12	12
Ambulation Difficulties	11	11
Leiomyosarcoma	11	11
No Known Impact Or Consequence To Patient	11	11
Arthralgia	9	9
Edema	8	8
No Information	8	8
Hematoma	6	6
Hypersensitivity/Allergic reaction	6	6
Necrosis	6	6
Swelling/ Edema	5	5
Hip Fracture	5	5
Toxicity	4	4
Joint Laxity	4	4
No Patient Involvement	4	4
Thrombosis	4	4
Swelling	4	4
Blood Loss	4	4
Implant Pain	4	4
Synovitis	4	4
Cyst(s)	4	4
Ossification	3	3
Distress	3	3
Bacterial Infection	3	3
Solid Tumour	3	3
Thrombus	2	2
Wound Dehiscence	2	2

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