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	1743	1743
Fracture	847	849
Adverse Event Without Identified Device or Use Problem	219	219
Material Twisted/Bent	215	215
Crack	194	194
Material Deformation	175	175
Naturally Worn	106	106
Connection Problem	85	85
Detachment of Device or Device Component	82	82
Material Fragmentation	73	73
Defective Device	73	73
Device Dislodged or Dislocated	56	57
Loose or Intermittent Connection	49	49
Mechanical Problem	49	49
Incomplete or Inadequate Connection	41	41
Mechanics Altered	40	40
Dull, Blunt	39	39
Mechanical Jam	35	35
Biocompatibility	26	26
Flaked	26	26
Loosening of Implant Not Related to Bone-Ingrowth	19	19
Physical Resistance/Sticking	18	18
Scratched Material	18	18
Material Separation	18	18
Corroded	17	17
Peeled/Delaminated	17	17
Component Missing	15	15
Degraded	14	14
Material Disintegration	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
Solder Joint Fracture	8	8
Activation, Positioning or Separation Problem	8	8
Unstable	8	8
Nonstandard Device	7	7
Material Erosion	7	7
Migration	6	6
Difficult or Delayed Separation	6	6
Appropriate Term/Code Not Available	6	6
Positioning Failure	6	6
Separation Failure	6	6
Failure to Align	5	5
Material Split, Cut or Torn	5	5
Off-Label Use	5	5
Sharp Edges	4	4
Misconnection	4	4
Migration or Expulsion of Device	4	4
Patient Device Interaction Problem	4	5

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
No Clinical Signs, Symptoms or Conditions	2984	2986
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	84	85
Insufficient Information	69	69
Pain	50	51
Metal Related Pathology	40	41
Unspecified Infection	36	36
Bone Fracture(s)	31	31
No Information	27	27
Foreign Body In Patient	27	27
Injury	23	23
Inadequate Osseointegration	19	19
Osteolysis	11	12
Deformity/ Disfigurement	10	10
Fall	10	10
Thrombosis/Thrombus	10	10
Ambulation Difficulties	9	9
No Code Available	8	8
Foreign Body Reaction	7	7
Device Embedded In Tissue or Plaque	6	6
Muscle/Tendon Damage	6	7
Subluxation	6	6
Bacterial Infection	5	6
Hip Fracture	5	5
Joint Laxity	5	5
Inflammation	5	5
Loss of Range of Motion	5	5
Post Operative Wound Infection	5	5
Hemorrhage/Bleeding	4	4
Non-union Bone Fracture	4	4
Swelling/ Edema	4	4
Perforation	4	4
Nerve Damage	4	4
Malunion of Bone	3	3
Fluid Discharge	3	3
Laceration(s)	3	3
Confusion/ Disorientation	3	3
Impaired Healing	3	3
Ossification	2	2
Osteopenia/ Osteoporosis	2	2
Unequal Limb Length	2	2
Balance Problems	2	2
Implant Pain	2	2
Synovitis	2	2
Dizziness	2	2
Unspecified Tissue Injury	2	2
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available	2	2

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