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	1671	1671
Fracture	681	681
Material Twisted/Bent	214	214
Adverse Event Without Identified Device or Use Problem	209	209
Crack	192	192
Material Deformation	160	160
Naturally Worn	106	106
Connection Problem	85	85
Detachment of Device or Device Component	73	73
Defective Device	73	73
Material Fragmentation	72	72
Device Dislodged or Dislocated	53	53
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
Loosening of Implant Not Related to Bone-Ingrowth	19	19
Material Separation	18	18
Physical Resistance/Sticking	18	18
Peeled/Delaminated	17	17
Corroded	17	17
Scratched Material	17	17
Component Missing	15	15
Material Disintegration	14	14
Degraded	13	13
Insufficient Information	10	10
Premature Separation	9	9
Deformation Due to Compressive Stress	8	8
Activation, Positioning or Separation Problem	8	8
Solder Joint Fracture	8	8
Inadequacy of Device Shape and/or Size	8	8
Unstable	7	7
Material Erosion	7	7
Nonstandard Device	7	7
Appropriate Term/Code Not Available	6	6
Migration	6	6
Difficult or Delayed Separation	6	6
Failure to Align	5	5
Separation Failure	5	5
Positioning Failure	5	5
Migration or Expulsion of Device	4	4
Misconnection	4	4
Device Damaged Prior to Use	4	4
Off-Label Use	4	4
Malposition of Device	4	4
Material Integrity Problem	4	4

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
No Clinical Signs, Symptoms or Conditions	2743	2743
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	91	91
Joint Dislocation	81	81
Insufficient Information	65	65
Pain	47	47
Metal Related Pathology	37	37
Unspecified Infection	36	36
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
Deformity/ Disfigurement	10	10
Thrombosis/Thrombus	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
Device Embedded In Tissue or Plaque	5	5
Post Operative Wound Infection	5	5
Hip Fracture	5	5
Bacterial Infection	5	5
Inflammation	5	5
Perforation	4	4
Non-union Bone Fracture	4	4
Swelling/ Edema	4	4
Hemorrhage/Bleeding	4	4
Muscle/Tendon Damage	4	4
Confusion/ Disorientation	3	3
Joint Laxity	3	3
Nerve Damage	3	3
Impaired Healing	3	3
Fluid Discharge	3	3
Malunion of Bone	3	3
Osteopenia/ Osteoporosis	2	2
Implant Pain	2	2
Ossification	2	2
Synovitis	2	2
Unspecified Tissue Injury	2	2
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available	2	2
Dizziness	2	2
Balance Problems	2	2
Laceration(s)	2	2
Tissue Breakdown	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