TPLC - Total Product Life Cycle

show TPLC since

Device	prosthesis, hip, semi-constrained, metal/polymer, uncemented
Regulation Description	Hip joint femoral (hemi-hip) metallic cemented or uncemented prosthesis.
Product Code	LWJ
Regulation Number	888.3360
Device Class	2

Device Problems	MDRs with this Device Problem	Events in those MDRs
Adverse Event Without Identified Device or Use Problem	112	114
Break	82	82
Insufficient Information	39	39
Device Dislodged or Dislocated	38	39
Fracture	38	38
Osseointegration Problem	20	22
Loss of Osseointegration	19	19
Mechanical Jam	17	17
Corroded	14	14
Detachment of Device or Device Component	14	14
Naturally Worn	8	8
Appropriate Term/Code Not Available	8	8
Migration	7	7
Degraded	7	7
Mechanical Problem	6	6
No Apparent Adverse Event	6	6
Noise, Audible	5	5
Biocompatibility	5	5
Device Appears to Trigger Rejection	4	4
Physical Resistance/Sticking	4	4
Delivered as Unsterile Product	4	4
Use of Device Problem	4	4
Loosening of Implant Not Related to Bone-Ingrowth	4	4
Tear, Rip or Hole in Device Packaging	3	3
Failure to Osseointegrate	3	3
Material Fragmentation	3	3
Difficult to Remove	3	3
Packaging Problem	2	2
Inadequacy of Device Shape and/or Size	2	2
Device Fell	2	2
Patient-Device Incompatibility	2	2
Malposition of Device	2	2
Loose or Intermittent Connection	2	2
Unstable	2	2
Scratched Material	1	1
Incorrect, Inadequate or Imprecise Result or Readings	1	1
Difficult to Insert	1	1
Positioning Problem	1	1
Measurement System Incompatibility	1	1
Defective Device	1	1
Material Deformation	1	1
Product Quality Problem	1	1
Expiration Date Error	1	1
Separation Failure	1	1
Material Disintegration	1	1
Crack	1	1
Output Problem	1	1
Coagulation in Device or Device Ingredient	1	1
Unexpected Therapeutic Results	1	1
Connection Problem	1	1

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
Insufficient Information	101	102
No Clinical Signs, Symptoms or Conditions	67	67
Failure of Implant	54	54
Pain	53	57
Bone Fracture(s)	45	45
Unspecified Infection	32	32
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available	25	26
Inadequate Osseointegration	22	24
Metal Related Pathology	21	22
Joint Laxity	12	13
Limb Fracture	11	12
Osteolysis	11	11
Foreign Body Reaction	11	13
Fall	10	11
Loss of Range of Motion	10	11
Hypersensitivity/Allergic reaction	7	9
Hip Fracture	7	7
Joint Dislocation	7	7
Discomfort	7	9
Bacterial Infection	5	5
Unequal Limb Length	5	5
Wound Dehiscence	4	4
Swelling/ Edema	4	5
Necrosis	4	5
Unspecified Tissue Injury	4	6
Ambulation Difficulties	3	5
Synovitis	3	3
Foreign Body In Patient	3	3
Distress	2	4
Hemorrhage/Bleeding	2	2
Subluxation	2	2
Thrombosis/Thrombus	2	2
Fever	2	2
Ossification	2	3
Implant Pain	2	2
Muscular Rigidity	1	2
Paresthesia	1	2
Post Traumatic Wound Infection	1	1
Depression	1	2
Numbness	1	2
Osteopenia/ Osteoporosis	1	1
Keratitis	1	1
Dyspnea	1	2
Purulent Discharge	1	1
Anemia	1	1
Inflammation	1	1
Muscle/Tendon Damage	1	2
Anxiety	1	2
Non-union Bone Fracture	1	1
Hematoma	1	1

Recalls
Manufacturer		Recall Class	Date Posted
1	Howmedica Osteonics Corp.	II	Jan-31-2024