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
DEPUY IRELAND UC
	SUBSTANTIALLY EQUIVALENT	1
HERAEUS MEDICAL GMBH
	SUBSTANTIALLY EQUIVALENT	1
HOWMEDICA OSTEONICS CORP., DBA STRYKER ORTHOPAEDICS
	SUBSTANTIALLY EQUIVALENT	1
OSTEOREMEDIES, LLC
	SUBSTANTIALLY EQUIVALENT	3
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	187	193
Biocompatibility	107	124
Loss of Osseointegration	76	76
Device-Device Incompatibility	59	59
Break	58	58
Material Twisted/Bent	48	48
Device Dislodged or Dislocated	38	38
Insufficient Device Problem Information	37	42
Loose or Intermittent Connection	29	29
Device Contaminated During Manufacture or Shipping	17	17
Fracture	16	16
Material Deformation	16	16
Osseointegration Problem	15	15
Scratched Material	14	14
Tear, Rip or Hole in Device Packaging	13	13
Naturally Worn	11	12
Detachment of Device or Device Component	10	10
Packaging Problem	10	10
Migration	9	9
Physical Resistance/Sticking	7	7
Corroded	7	7
Computer System Security Problem	7	7
Material Integrity Problem	7	7
Mechanical Jam	5	5
Patient Device Interaction Problem	5	7
Unstable	4	4
Compatibility Problem	4	4
Malposition of Device	4	4
Patient-Device Incompatibility	4	4
Defective Device	4	4
Degraded	4	5
Loss of or Failure to Bond	3	3
Unintended Movement	3	3
Loosening of Implant Not Related to Bone-Ingrowth	3	3
Failure to Osseointegrate	3	3
Inadequacy of Device Shape and/or Size	3	3
No Apparent Adverse Event	2	2
Difficult to Insert	2	2
Unsealed Device Packaging	2	2
Device Damaged Prior to Use	2	2
Crack	2	2
Entrapment of Device	2	2
Failure to Align	1	1
Use of Device Problem	1	1
Appropriate Device Problem Term/Code Not Available	1	1
Material Discolored	1	1
Difficult to Remove	1	1
Difficult to Advance	1	1
Device Markings/Labelling Problem	1	1
Off-Label Use	1	1

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
Metal Related Pathology	123	142
No Code Available	119	119
Insufficient Information	117	124
No Consequences Or Impact To Patient	107	107
Pain	101	111
Unspecified Infection	78	79
No Clinical Signs, Symptoms or Conditions	45	45
Joint Dislocation	43	43
Bone Fracture(s)	36	36
Inadequate Osseointegration	33	33
Failure of Implant	32	34
Osteolysis	21	25
Injury	20	22
Infiltration into Tissue	15	18
High metal ion levels	15	20
Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available	15	15
Not Applicable	12	12
Loss of Range of Motion	12	15
Arthralgia	11	13
Fall	11	11
Leiomyosarcoma	11	11
Ambulation or Postural Difficulties	11	14
Foreign Body Reaction	7	7
No Known Impact Or Consequence To Patient	7	7
Limited Mobility Of The Implanted Joint	6	6
Necrosis	6	6
Swelling/ Edema	6	7
Joint Laxity	6	7
Limb Fracture	6	6
Test Result	5	5
Inflammation	5	6
Implant Pain	5	5
Bacterial Infection	4	5
Hip Fracture	4	4
Synovitis	4	5
Edema	4	4
No Patient Involvement	4	4
Discomfort	4	4
Solid Tumour	3	5
Toxicity	3	3
Muscle/Tendon Damage	3	3
Hematoma	3	3
Hypersensitivity/Allergic reaction	3	3
Medical device site infection	3	4
Extraskeletal ossification	3	3
Tinnitus	2	2
Headache	2	2
Fluid Discharge	2	2
Unspecified Eye / Vision Problem	2	2
Muscle Weakness/Atrophy	2	2

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