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	1

Device Problems	MDRs with this Device Problem	Events in those MDRs
Adverse Event Without Identified Device or Use Problem	171	171
Biocompatibility	98	98
Loss of Osseointegration	76	76
Device-Device Incompatibility	59	59
Break	56	56
Material Twisted/Bent	48	48
Device Dislodged or Dislocated	37	37
Insufficient Information	34	34
Loose or Intermittent Connection	28	28
Appropriate Term/Code Not Available	21	21
Device Contaminated During Manufacture or Shipping	16	16
Scratched Material	14	14
Tear, Rip or Hole in Device Packaging	13	13
Material Deformation	13	13
Fracture	12	12
Naturally Worn	11	11
Packaging Problem	10	10
Migration	9	9
Detachment of Device or Device Component	8	8
Osseointegration Problem	7	7
Computer System Security Problem	7	7
Physical Resistance/Sticking	7	7
Material Integrity Problem	7	7
Corroded	6	6
Degraded	5	5
Patient Device Interaction Problem	5	5
Defective Device	4	4
Malposition of Device	4	4
Mechanical Jam	4	4
Compatibility Problem	4	4
Unstable	4	4
Material Fragmentation	3	3
Failure to Osseointegrate	3	3
Inadequacy of Device Shape and/or Size	3	3
Loosening of Implant Not Related to Bone-Ingrowth	2	2
Difficult to Insert	2	2
Unsealed Device Packaging	2	2
Unintended Movement	2	2
Patient-Device Incompatibility	2	2
No Apparent Adverse Event	2	2
Device Damaged Prior to Use	2	2
Crack	2	2
Entrapment of Device	2	2
Difficult to Remove	1	1
Material Discolored	1	1
Use of Device Problem	1	1
Therapeutic or Diagnostic Output Failure	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
No Code Available	119	119
Insufficient Information	113	113
Metal Related Pathology	112	112
No Consequences Or Impact To Patient	107	107
Pain	91	91
Unspecified Infection	66	66
Bone Fracture(s)	36	36
No Clinical Signs, Symptoms or Conditions	35	35
Joint Dislocation	33	33
Failure of Implant	29	29
Inadequate Osseointegration	24	24
Osteolysis	20	20
Injury	20	20
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available	15	15
Infiltration into Tissue	15	15
Not Applicable	12	12
Loss of Range of Motion	12	12
Arthralgia	11	11
Leiomyosarcoma	11	11
Ambulation Difficulties	10	10
Fall	9	9
No Known Impact Or Consequence To Patient	7	7
Limited Mobility Of The Implanted Joint	6	6
Foreign Body Reaction	6	6
Swelling/ Edema	5	5
Test Result	5	5
Joint Laxity	4	4
Necrosis	4	4
Hip Fracture	4	4
Inflammation	4	4
Synovitis	4	4
Implant Pain	4	4
Edema	4	4
No Patient Involvement	4	4
Hypersensitivity/Allergic reaction	3	3
Discomfort	3	3
Bacterial Infection	3	3
Ossification	3	3
Hematoma	3	3
Solid Tumour	3	3
Foreign Body In Patient	2	2
Muscle Weakness	2	2
Cyst(s)	2	2
Unspecified Eye / Vision Problem	2	2
Toxicity	2	2
Wound Dehiscence	2	2
Muscle/Tendon Damage	2	2
Hypoesthesia	1	1
Hemorrhage/Bleeding	1	1
Headache	1	1

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