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	97	102
Insufficient Information	46	46
Loosening of Implant Not Related to Bone-Ingrowth	38	38
Device Dislodged or Dislocated	26	44
Fracture	16	16
Detachment of Device or Device Component	12	12
Migration or Expulsion of Device	11	11
Mechanical Problem	10	10
Naturally Worn	9	9
Loss of Osseointegration	8	8
Appropriate Term/Code Not Available	8	8
Break	8	8
Disassembly	7	7
Loose or Intermittent Connection	6	6
Migration	6	6
Loss of or Failure to Bond	4	4
Unstable	4	4
Use of Device Problem	4	4
Patient Device Interaction Problem	4	4
Unintended Movement	3	3
Osseointegration Problem	3	3
Improper or Incorrect Procedure or Method	3	3
Device Slipped	3	3
Material Erosion	2	2
Packaging Problem	2	2
Device Operates Differently Than Expected	2	2
Compatibility Problem	2	2
Inaccurate Information	2	2
Manufacturing, Packaging or Shipping Problem	1	1
Material Integrity Problem	1	1
Positioning Problem	1	1
Protective Measures Problem	1	1
Therapeutic or Diagnostic Output Failure	1	1
Missing Value Reason	1	1
Detachment Of Device Component	1	1
Degraded	1	1
Difficult to Insert	1	1
Misassembled	1	1
Product Quality Problem	1	1
Fitting Problem	1	1
Component Missing	1	1
Device Issue	1	1

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
Unspecified Infection	49	53
Failure of Implant	47	47
Pain	43	43
No Information	38	38
No Code Available	34	34
Insufficient Information	23	41
Implant Pain	20	20
No Known Impact Or Consequence To Patient	19	19
Loss of Range of Motion	19	19
Bone Fracture(s)	16	16
Joint Laxity	10	11
No Clinical Signs, Symptoms or Conditions	8	8
Injury	7	7
Swelling/ Edema	6	6
Post Operative Wound Infection	5	5
Joint Dislocation	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
Reaction	4	4
Fluid Discharge	4	4
Patient Problem/Medical Problem	4	4
Inadequate Osseointegration	3	3
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
Post Traumatic Wound Infection	2	2
Foreign Body In Patient	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