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	1745	1745
Insufficient Information	977	977
Fracture	638	638
Adverse Event Without Identified Device or Use Problem	415	415
Device Dislodged or Dislocated	229	229
Material Twisted/Bent	213	213
Crack	194	194
Appropriate Term/Code Not Available	182	182
Material Deformation	168	168
Naturally Worn	153	153
Connection Problem	98	98
Loss of Osseointegration	93	93
Corroded	78	78
Defective Device	73	73
Detachment of Device or Device Component	72	72
Material Fragmentation	68	68
Loose or Intermittent Connection	64	64
Mechanical Problem	53	53
Unstable	46	46
Incomplete or Inadequate Connection	41	41
Biocompatibility	39	39
Migration or Expulsion of Device	39	39
Dull, Blunt	38	38
Mechanics Altered	37	37
Noise, Audible	36	36
Degraded	31	31
Mechanical Jam	30	30
Malposition of Device	29	29
Material Erosion	29	29
Flaked	26	26
Metal Shedding Debris	25	25
Loosening of Implant Not Related to Bone-Ingrowth	24	24
Loss of or Failure to Bond	19	19
Physical Resistance/Sticking	18	18
Migration	18	18
Material Separation	18	18
Scratched Material	17	17
Peeled/Delaminated	17	17
Component Missing	15	15
Material Disintegration	15	15
Device Slipped	14	14
Nonstandard Device	10	10
Inadequacy of Device Shape and/or Size	9	9
Activation, Positioning or Separation Problem	8	8
Deformation Due to Compressive Stress	8	8
Material Integrity Problem	8	8
Premature Separation	8	8
Positioning Problem	7	7
Solder Joint Fracture	7	7
Osseointegration Problem	7	7

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
No Clinical Signs, Symptoms or Conditions	2603	2603
Pain	722	722
No Information	454	454
No Code Available	388	388
No Known Impact Or Consequence To Patient	379	379
Injury	267	267
No Patient Involvement	238	238
No Consequences Or Impact To Patient	217	217
Unspecified Infection	193	193
Joint Dislocation	189	189
Host-Tissue Reaction	136	136
Inflammation	117	117
Discomfort	115	115
Bone Fracture(s)	107	107
Failure of Implant	104	104
Foreign Body Reaction	97	97
Osteolysis	85	85
Tissue Damage	81	81
Reaction	80	80
Test Result	68	68
Not Applicable	63	63
Insufficient Information	60	60
Inadequate Osseointegration	56	56
Metal Related Pathology	42	42
Limited Mobility Of The Implanted Joint	41	41
Loss of Range of Motion	37	37
Foreign Body In Patient	27	27
Ambulation Difficulties	25	25
Swelling	25	25
Fall	24	24
Toxicity	22	22
Deformity/ Disfigurement	18	18
Hip Fracture	14	14
Bacterial Infection	12	12
Hypersensitivity/Allergic reaction	11	11
Death	10	10
Thrombosis/Thrombus	10	10
Necrosis	9	9
Device Embedded In Tissue or Plaque	9	9
Blood Loss	9	9
Impaired Healing	9	9
Distress	8	8
Synovitis	8	8
Cyst(s)	7	7
Nerve Damage	7	7
Edema	7	7
Local Reaction	7	7
Ossification	7	7
Subluxation	6	6
Swelling/ Edema	6	6

Recalls
Manufacturer		Recall Class	Date Posted
1	Howmedica Osteonics Corp.	II	Feb-17-2022
2	Howmedica Osteonics Corp.	II	Nov-30-2021
3	Stryker Howmedica Osteonics Corp.	II	Nov-23-2009
4	Waldemar Link GmbH & Co. KG (Mfg Site)	II	Mar-14-2024
5	Zimmer, Inc.	II	Aug-26-2014
6	Zimmer, Inc.	II	Aug-13-2014
7	Zimmer, Inc.	II	Feb-20-2014
8	Zimmer, Inc.	II	Aug-17-2013