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	1
TECRES S.P.A.
	SUBSTANTIALLY EQUIVALENT	1

Device Problems	MDRs with this Device Problem	Events in those MDRs
Biocompatibility	105	122
Adverse Event Without Identified Device or Use Problem	99	101
Loss of Osseointegration	61	61
Device Dislodged or Dislocated	35	35
Insufficient Information	33	38
Break	17	17
Appropriate Term/Code Not Available	14	14
Tear, Rip or Hole in Device Packaging	12	12
Device Contaminated During Manufacture or Shipping	10	10
Packaging Problem	10	10
Detachment of Device or Device Component	9	9
Fracture	9	9
Naturally Worn	9	10
Computer System Security Problem	7	7
Unstable	4	4
Corroded	4	4
Malposition of Device	3	3
Loosening of Implant Not Related to Bone-Ingrowth	3	3
Degraded	3	4
Failure to Osseointegrate	3	3
Patient-Device Incompatibility	2	2
Unsealed Device Packaging	2	2
Patient Device Interaction Problem	2	2
Material Fragmentation	2	2
No Apparent Adverse Event	2	2
Loss of or Failure to Bond	2	2
Device-Device Incompatibility	1	1
Separation Problem	1	1
Off-Label Use	1	1
Device Markings/Labelling Problem	1	1
Unintended Movement	1	1
Material Integrity Problem	1	1
Therapeutic or Diagnostic Output Failure	1	1
Difficult to Insert	1	1
Use of Device Problem	1	1
Mechanical Jam	1	1
Noise, Audible	1	1

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
Insufficient Information	113	120
Metal Related Pathology	112	127
Pain	71	79
Unspecified Infection	47	48
Joint Dislocation	38	38
No Clinical Signs, Symptoms or Conditions	37	37
Failure of Implant	22	24
Osteolysis	16	20
Infiltration into Tissue	15	18
Bone Fracture(s)	15	15
Leiomyosarcoma	11	11
Arthralgia	11	13
Loss of Range of Motion	10	13
Ambulation Difficulties	9	12
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available	7	7
Inadequate Osseointegration	5	5
Necrosis	5	5
Implant Pain	5	5
Joint Laxity	4	5
Synovitis	4	5
Solid Tumour	3	5
Swelling/ Edema	3	3
Hematoma	3	3
Inflammation	3	4
Foreign Body Reaction	3	3
Tinnitus	2	2
Headache	2	2
Bacterial Infection	2	2
Muscle/Tendon Damage	2	2
Limb Fracture	2	2
Fall	2	2
Unspecified Eye / Vision Problem	2	2
No Patient Involvement	2	2
Discomfort	2	2
No Known Impact Or Consequence To Patient	2	2
Ossification	2	2
Cramp(s) /Muscle Spasm(s)	2	2
Muscle Weakness	2	2
Hip Fracture	2	2
Wound Dehiscence	2	2
Thrombosis/Thrombus	1	1
Diarrhea	1	1
Unspecified Mental, Emotional or Behavioural Problem	1	2
Vomiting	1	1
Foreign Body In Patient	1	1
Numbness	1	1
Unequal Limb Length	1	1
Osteopenia/ Osteoporosis	1	1
Abrasion	1	1
Scar Tissue	1	1

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