TPLC - Total Product Life Cycle

show TPLC since

Device	prosthesis, hip, femoral component, cemented, metal
Product Code	JDG
Regulation Number	888.3360
Device Class	2

Device Problems	MDRs with this Device Problem	Events in those MDRs
Break	1657	1657
Fracture	649	649
Material Twisted/Bent	212	212
Adverse Event Without Identified Device or Use Problem	206	206
Crack	192	192
Material Deformation	159	159
Naturally Worn	106	106
Connection Problem	85	85
Defective Device	73	73
Material Fragmentation	70	70
Detachment of Device or Device Component	70	70
Device Dislodged or Dislocated	50	50
Loose or Intermittent Connection	49	49
Mechanical Problem	48	48
Incomplete or Inadequate Connection	41	41
Dull, Blunt	38	38
Mechanics Altered	38	38
Mechanical Jam	32	32
Flaked	25	25
Biocompatibility	24	24
Physical Resistance/Sticking	18	18
Material Separation	18	18
Corroded	17	17
Peeled/Delaminated	17	17
Scratched Material	17	17
Loosening of Implant Not Related to Bone-Ingrowth	17	17
Component Missing	15	15
Material Disintegration	14	14
Degraded	13	13
Insufficient Information	10	10
Premature Separation	8	8
Deformation Due to Compressive Stress	8	8
Inadequacy of Device Shape and/or Size	8	8
Activation, Positioning or Separation Problem	8	8
Solder Joint Fracture	8	8
Material Erosion	7	7
Nonstandard Device	7	7
Unstable	7	7
Appropriate Term/Code Not Available	6	6
Migration	6	6
Difficult or Delayed Separation	6	6
Failure to Align	5	5
Positioning Failure	5	5
Sharp Edges	4	4
Misconnection	4	4
Patient Device Interaction Problem	4	4
Material Integrity Problem	4	4
Separation Failure	4	4
Device Damaged Prior to Use	4	4
Malposition of Device	4	4

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
No Clinical Signs, Symptoms or Conditions	2694	2694
No Known Impact Or Consequence To Patient	350	350
No Patient Involvement	237	237
No Consequences Or Impact To Patient	119	119
Failure of Implant	89	89
Joint Dislocation	78	78
Insufficient Information	62	62
Pain	46	46
Unspecified Infection	37	37
Metal Related Pathology	37	37
Bone Fracture(s)	30	30
No Information	27	27
Foreign Body In Patient	25	25
Injury	23	23
Inadequate Osseointegration	19	19
Osteolysis	11	11
Thrombosis/Thrombus	10	10
Deformity/ Disfigurement	10	10
Fall	9	9
No Code Available	8	8
Foreign Body Reaction	7	7
Subluxation	6	6
Ambulation Difficulties	6	6
Loss of Range of Motion	5	5
Post Operative Wound Infection	5	5
Bacterial Infection	5	5
Inflammation	5	5
Device Embedded In Tissue or Plaque	5	5
Hip Fracture	5	5
Hemorrhage/Bleeding	4	4
Perforation	4	4
Swelling/ Edema	4	4
Non-union Bone Fracture	4	4
Muscle/Tendon Damage	4	4
Confusion/ Disorientation	3	3
Nerve Damage	3	3
Joint Laxity	3	3
Fluid Discharge	3	3
Impaired Healing	3	3
Malunion of Bone	3	3
Osteopenia/ Osteoporosis	2	2
Implant Pain	2	2
Ossification	2	2
Synovitis	2	2
Dizziness	2	2
Unspecified Tissue Injury	2	2
Laceration(s)	2	2
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available	2	2
Balance Problems	2	2
Skin Tears	1	1

Recalls
Manufacturer		Recall Class	Date Posted
1	Howmedica Osteonics Corp.	II	Feb-17-2022
2	Howmedica Osteonics Corp.	II	Nov-30-2021
3	Waldemar Link GmbH & Co. KG (Mfg Site)	II	Mar-14-2024