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	180	186
Biocompatibility	106	123
Loss of Osseointegration	76	76
Device-Device Incompatibility	59	59
Break	57	57
Material Twisted/Bent	48	48
Device Dislodged or Dislocated	41	41
Insufficient Information	37	42
Loose or Intermittent Connection	28	28
Appropriate Term/Code Not Available	21	21
Device Contaminated During Manufacture or Shipping	16	16
Fracture	15	15
Scratched Material	14	14
Tear, Rip or Hole in Device Packaging	13	13
Material Deformation	13	13
Naturally Worn	11	12
Detachment of Device or Device Component	10	10
Packaging Problem	10	10
Migration	9	9
Corroded	8	8
Osseointegration Problem	7	7
Physical Resistance/Sticking	7	7
Computer System Security Problem	7	7
Material Integrity Problem	7	7
Mechanical Jam	5	5
Malposition of Device	5	5
Patient Device Interaction Problem	5	7
Degraded	5	6
Unstable	4	4
Compatibility Problem	4	4
Patient-Device Incompatibility	4	4
Defective Device	4	4
Loss of or Failure to Bond	3	3
Loosening of Implant Not Related to Bone-Ingrowth	3	3
Material Fragmentation	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
Unintended Movement	2	2
Device Damaged Prior to Use	2	2
Crack	2	2
Entrapment of Device	2	2
Use of Device Problem	1	1
Material Discolored	1	1
Device Contamination with Chemical or Other Material	1	1
Difficult to Remove	1	1
Therapeutic or Diagnostic Output Failure	1	1
Difficult to Advance	1	1

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
Metal Related Pathology	122	141
No Code Available	119	119
Insufficient Information	114	121
No Consequences Or Impact To Patient	107	107
Pain	98	108
Unspecified Infection	72	73
Joint Dislocation	39	39
No Clinical Signs, Symptoms or Conditions	39	39
Bone Fracture(s)	36	36
Failure of Implant	32	34
Inadequate Osseointegration	25	25
Osteolysis	21	25
Injury	20	22
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available	15	15
Infiltration into Tissue	15	18
Not Applicable	12	12
Loss of Range of Motion	12	15
Arthralgia	11	13
Ambulation Difficulties	11	14
Leiomyosarcoma	11	11
Fall	9	9
No Known Impact Or Consequence To Patient	7	7
Foreign Body Reaction	7	7
Limited Mobility Of The Implanted Joint	6	6
Necrosis	6	6
Swelling/ Edema	5	6
Test Result	5	5
Inflammation	5	6
Implant Pain	5	5
Joint Laxity	4	5
No Patient Involvement	4	4
Bacterial Infection	4	5
Edema	4	4
Synovitis	4	5
Hip Fracture	4	4
Hematoma	3	3
Ossification	3	3
Discomfort	3	3
Solid Tumour	3	5
Hypersensitivity/Allergic reaction	3	3
Toxicity	3	3
Muscle/Tendon Damage	3	3
Cramp(s) /Muscle Spasm(s)	2	2
Muscle Weakness	2	2
Headache	2	2
Cyst(s)	2	3
Tinnitus	2	2
Unspecified Eye / Vision Problem	2	2
Wound Dehiscence	2	2
Limb Fracture	2	2

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