TPLC - Total Product Life Cycle

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Device	prosthesis, hip, femoral component, cemented, metal
Regulation Description	Hip joint femoral (hemi-hip) metallic cemented or uncemented prosthesis.
Product Code	JDG
Regulation Number	888.3360
Device Class	2

Device Problems	MDRs with this Device Problem	Events in those MDRs
Break	1237	1237
Fracture	829	831
Adverse Event Without Identified Device or Use Problem	203	203
Crack	160	160
Material Twisted/Bent	127	127
Material Deformation	110	110
Naturally Worn	82	82
Detachment of Device or Device Component	78	78
Material Fragmentation	54	54
Device Dislodged or Dislocated	54	55
Connection Problem	34	34
Incomplete or Inadequate Connection	31	31
Loose or Intermittent Connection	29	29
Biocompatibility	26	26
Mechanics Altered	22	22
Mechanical Jam	22	22
Flaked	20	20
Dull, Blunt	19	19
Loosening of Implant Not Related to Bone-Ingrowth	19	19
Scratched Material	17	17
Physical Resistance/Sticking	15	15
Peeled/Delaminated	15	15
Corroded	14	14
Mechanical Problem	12	12
Premature Separation	12	12
Component Missing	11	11
Degraded	9	9
Defective Device	8	8
Material Erosion	7	7
Migration	6	6
Insufficient Information	6	6
Difficult or Delayed Separation	6	6
Positioning Failure	6	6
Off-Label Use	5	5
Solder Joint Fracture	5	5
Deformation Due to Compressive Stress	5	5
Unstable	5	5
Material Separation	4	4
Patient Device Interaction Problem	4	5
Separation Failure	4	4
Migration or Expulsion of Device	4	4
Improper or Incorrect Procedure or Method	3	3
Misconnection	3	3
Problem with Sterilization	3	3
Difficult to Remove	3	3
Malposition of Device	3	3
Material Split, Cut or Torn	3	3
Fitting Problem	3	3
Device Damaged by Another Device	2	2
Delivered as Unsterile Product	2	2

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
No Clinical Signs, Symptoms or Conditions	2604	2606
Joint Dislocation	83	84
Failure of Implant	80	80
Insufficient Information	69	69
Pain	45	46
Metal Related Pathology	38	39
Unspecified Infection	32	32
Bone Fracture(s)	29	29
Inadequate Osseointegration	19	19
Osteolysis	11	12
Deformity/ Disfigurement	10	10
Fall	10	10
Foreign Body In Patient	10	10
Thrombosis/Thrombus	10	10
Ambulation Difficulties	9	9
Muscle/Tendon Damage	6	7
Subluxation	6	6
Hip Fracture	5	5
Bacterial Infection	5	6
Joint Laxity	5	5
Inflammation	5	5
Post Operative Wound Infection	5	5
Loss of Range of Motion	5	5
Device Embedded In Tissue or Plaque	4	4
Hemorrhage/Bleeding	4	4
Non-union Bone Fracture	4	4
Perforation	4	4
Nerve Damage	4	4
Impaired Healing	3	3
Swelling/ Edema	3	3
Malunion of Bone	3	3
Fluid Discharge	3	3
Laceration(s)	3	3
Foreign Body Reaction	3	3
Confusion/ Disorientation	3	3
Unspecified Tissue Injury	2	2
Balance Problems	2	2
Unequal Limb Length	2	2
Ossification	2	2
Osteopenia/ Osteoporosis	2	2
Implant Pain	2	2
Synovitis	2	2
Dizziness	2	2
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available	2	2
Discomfort	1	1
Needle Stick/Puncture	1	1
Seroma	1	1
Movement Disorder	1	1
Purulent Discharge	1	1
Scar Tissue	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	Aug-11-2025
4	Waldemar Link GmbH & Co. KG (Mfg Site)	II	Mar-14-2024