TPLC - Total Product Life Cycle

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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	1712	1712
Fracture	592	592
Adverse Event Without Identified Device or Use Problem	283	283
Material Twisted/Bent	212	212
Crack	192	192
Material Deformation	159	159
Naturally Worn	115	115
Connection Problem	98	98
Defective Device	73	73
Device Dislodged or Dislocated	73	73
Material Fragmentation	68	68
Detachment of Device or Device Component	67	67
Insufficient Information	61	61
Loose or Intermittent Connection	51	51
Mechanical Problem	48	48
Incomplete or Inadequate Connection	41	41
Dull, Blunt	38	38
Mechanics Altered	37	37
Biocompatibility	36	36
Mechanical Jam	30	30
Corroded	28	28
Unstable	27	27
Flaked	26	26
Loosening of Implant Not Related to Bone-Ingrowth	22	22
Degraded	21	21
Physical Resistance/Sticking	18	18
Material Separation	18	18
Peeled/Delaminated	17	17
Scratched Material	17	17
Component Missing	15	15
Material Disintegration	14	14
Material Erosion	10	10
Appropriate Term/Code Not Available	10	10
Migration	9	9
Premature Separation	8	8
Inadequacy of Device Shape and/or Size	8	8
Deformation Due to Compressive Stress	8	8
Loss of Osseointegration	8	8
Activation, Positioning or Separation Problem	8	8
Nonstandard Device	7	7
Failure to Align	7	7
Solder Joint Fracture	6	6
Difficult or Delayed Separation	6	6
Positioning Failure	5	5
Material Integrity Problem	5	5
Noise, Audible	4	4
Loss of or Failure to Bond	4	4
Material Split, Cut or Torn	4	4
Migration or Expulsion of Device	4	4
Patient Device Interaction Problem	4	4

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
No Clinical Signs, Symptoms or Conditions	2603	2603
No Known Impact Or Consequence To Patient	353	353
No Patient Involvement	237	237
No Consequences Or Impact To Patient	207	207
No Code Available	104	104
Injury	103	103
Joint Dislocation	100	100
Pain	95	95
Failure of Implant	94	94
Unspecified Infection	74	74
Insufficient Information	60	60
No Information	46	46
Bone Fracture(s)	45	45
Test Result	41	41
Metal Related Pathology	38	38
Tissue Damage	34	34
Inadequate Osseointegration	27	27
Foreign Body In Patient	25	25
Osteolysis	24	24
Inflammation	18	18
Limited Mobility Of The Implanted Joint	17	17
Loss of Range of Motion	14	14
Foreign Body Reaction	14	14
Discomfort	12	12
Deformity/ Disfigurement	11	11
Fall	10	10
Thrombosis/Thrombus	10	10
Ambulation Difficulties	8	8
Hip Fracture	7	7
Reaction	7	7
Device Embedded In Tissue or Plaque	6	6
Subluxation	6	6
Swelling	6	6
Bacterial Infection	5	5
Post Operative Wound Infection	5	5
Hemorrhage/Bleeding	4	4
Swelling/ Edema	4	4
Non-union Bone Fracture	4	4
Nerve Damage	4	4
Fatigue	4	4
Death	4	4
Perforation	4	4
Muscle/Tendon Damage	3	3
Malunion of Bone	3	3
Fluid Discharge	3	3
Joint Laxity	3	3
Scar Tissue	3	3
Not Applicable	3	3
Necrosis	3	3
Local Reaction	3	3

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