TPLC - Total Product Life Cycle

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Device	prosthesis, elbow, semi-constrained, cemented
Product Code	JDB
Regulation Number	888.3160
Device Class	2

Device Problems	MDRs with this Device Problem	Events in those MDRs
Adverse Event Without Identified Device or Use Problem	102	107
Insufficient Information	46	46
Loosening of Implant Not Related to Bone-Ingrowth	38	38
Device Dislodged or Dislocated	29	47
Unstable	16	25
Fracture	16	16
Osseointegration Problem	13	21
Detachment of Device or Device Component	12	12
Migration or Expulsion of Device	11	11
Mechanical Problem	10	10
Naturally Worn	9	9
Appropriate Term/Code Not Available	9	9
Break	8	8
Loss of Osseointegration	8	8
Disassembly	7	7
Migration	6	6
Loose or Intermittent Connection	6	6
Patient Device Interaction Problem	5	5
Loss of or Failure to Bond	4	4
Use of Device Problem	4	4
Improper or Incorrect Procedure or Method	3	3
Unintended Movement	3	3
Device Slipped	3	3
Packaging Problem	2	2
Material Erosion	2	2
Malposition of Device	2	2
Inaccurate Information	2	2
Compatibility Problem	2	2
Device Operates Differently Than Expected	2	2
Product Quality Problem	1	1
Material Integrity Problem	1	1
Component Missing	1	1
Degraded	1	1
Therapeutic or Diagnostic Output Failure	1	1
Misassembled	1	1
Device Issue	1	1
Protective Measures Problem	1	1
Fitting Problem	1	1
Detachment Of Device Component	1	1
Positioning Problem	1	1
Manufacturing, Packaging or Shipping Problem	1	1
Difficult to Insert	1	1
Missing Value Reason	1	1

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
Unspecified Infection	54	58
Failure of Implant	47	47
Pain	43	43
No Information	38	38
No Code Available	34	34
Insufficient Information	23	41
Joint Laxity	21	30
Loss of Range of Motion	21	21
Implant Pain	20	20
No Known Impact Or Consequence To Patient	19	19
Bone Fracture(s)	17	17
Inadequate Osseointegration	14	22
No Clinical Signs, Symptoms or Conditions	8	8
Injury	7	7
Joint Dislocation	7	7
Swelling/ Edema	6	6
Post Operative Wound Infection	5	5
Discomfort	5	5
Tissue Damage	5	5
Inflammation	5	5
Death	4	4
Rheumatoid Arthritis	4	4
Bacterial Infection	4	4
Ossification	4	4
Neuropathy	4	4
Osteolysis	4	4
Fluid Discharge	4	4
Reaction	4	4
Patient Problem/Medical Problem	4	4
Rupture	3	3
Sepsis	3	3
Swelling	2	2
Tingling	2	2
No Consequences Or Impact To Patient	2	2
Impaired Healing	2	2
Fracture, Arm	2	2
Wound Dehiscence	2	2
Cyst(s)	2	2
Nerve Damage	2	2
Foreign Body In Patient	2	2
Post Traumatic Wound Infection	2	2
Limb Fracture	2	2
Unspecified Tissue Injury	1	1
Device Embedded In Tissue or Plaque	1	1
Undesired Nerve Stimulation	1	1
Necrosis	1	1
Fall	1	1
Foreign Body Reaction	1	1
Hypersensitivity/Allergic reaction	1	1
Adhesion(s)	1	1
Erosion	1	1
Bronchitis	1	1
Burning Sensation	1	1
Scar Tissue	1	1

Recalls
Manufacturer		Recall Class	Date Posted
1	Howmedica Osteonics Corp.	II	Aug-08-2018
2	Stryker Howmedica Osteonics Corp.	II	Aug-20-2015
3	Tornier, Inc	II	Aug-29-2011