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	1708	1708
Fracture	782	782
Adverse Event Without Identified Device or Use Problem	217	217
Material Twisted/Bent	215	215
Crack	194	194
Material Deformation	168	168
Naturally Worn	106	106
Connection Problem	85	85
Detachment of Device or Device Component	79	79
Material Fragmentation	73	73
Defective Device	73	73
Device Dislodged or Dislocated	55	55
Mechanical Problem	49	49
Loose or Intermittent Connection	49	49
Incomplete or Inadequate Connection	41	41
Dull, Blunt	39	39
Mechanics Altered	39	39
Mechanical Jam	34	34
Biocompatibility	26	26
Flaked	25	25
Loosening of Implant Not Related to Bone-Ingrowth	19	19
Physical Resistance/Sticking	18	18
Material Separation	18	18
Scratched Material	18	18
Corroded	17	17
Peeled/Delaminated	17	17
Component Missing	15	15
Material Disintegration	14	14
Degraded	14	14
Premature Separation	12	12
Insufficient Information	10	10
Deformation Due to Compressive Stress	9	9
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
Positioning Failure	6	6
Separation Failure	6	6
Failure to Align	5	5
Off-Label Use	5	5
Material Split, Cut or Torn	5	5
Sharp Edges	4	4
Misconnection	4	4
Patient Device Interaction Problem	4	4
Material Integrity Problem	4	4

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
No Clinical Signs, Symptoms or Conditions	2883	2883
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	92	92
Joint Dislocation	83	83
Insufficient Information	69	69
Pain	49	49
Metal Related Pathology	39	39
Unspecified Infection	36	36
Bone Fracture(s)	30	30
No Information	27	27
Foreign Body In Patient	26	26
Injury	23	23
Inadequate Osseointegration	19	19
Osteolysis	11	11
Fall	10	10
Thrombosis/Thrombus	10	10
Deformity/ Disfigurement	10	10
Ambulation Difficulties	8	8
No Code Available	8	8
Foreign Body Reaction	7	7
Subluxation	6	6
Muscle/Tendon Damage	5	5
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
Joint Laxity	4	4
Non-union Bone Fracture	4	4
Confusion/ Disorientation	3	3
Nerve Damage	3	3
Laceration(s)	3	3
Fluid Discharge	3	3
Malunion of Bone	3	3
Impaired Healing	3	3
Osteopenia/ Osteoporosis	2	2
Ossification	2	2
Implant Pain	2	2
Synovitis	2	2
Dizziness	2	2
Unspecified Tissue Injury	2	2
Balance Problems	2	2
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available	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	Aug-11-2025
4	Waldemar Link GmbH & Co. KG (Mfg Site)	II	Mar-14-2024