TPLC - Total Product Life Cycle

show TPLC since

Device	prosthesis, shoulder, semi-constrained, metal/polymer + additive, cemented
Definition	Total shoulders are indicated for arthritis (osteo-, rheumatoid, traumatic), avascular necrosis, correction of functional deformity, and revision procedures.
Product Code	PAO
Regulation Number	888.3660
Device Class	2

Device Problems	MDRs with this Device Problem	Events in those MDRs
Adverse Event Without Identified Device or Use Problem	138	138
Insufficient Information	115	115
Device Dislodged or Dislocated	89	89
Fracture	83	83
Difficult to Insert	40	40
Unstable	39	39
Migration or Expulsion of Device	20	20
Appropriate Term/Code Not Available	17	17
Detachment Of Device Component	11	11
Fitting Problem	10	10
Difficult To Position	9	9
Device-Device Incompatibility	8	8
Naturally Worn	8	8
Device Operates Differently Than Expected	8	8
Detachment of Device or Device Component	6	6
Noise, Audible	5	5
Material Erosion	5	5
Loose or Intermittent Connection	5	5
Device Damaged by Another Device	5	5
Disassembly	5	5
Malposition of Device	5	5
Bent	4	4
No Apparent Adverse Event	4	4
Mechanical Problem	4	4
Break	4	4
Loosening of Implant Not Related to Bone-Ingrowth	3	3
Metal Shedding Debris	3	3
Packaging Problem	3	3
Device Slipped	3	3
Positioning Problem	2	2
Off-Label Use	2	2
Positioning Failure	2	2
Inadequacy of Device Shape and/or Size	2	2
Migration	2	2
Material Deformation	2	2
Material Separation	2	2
Difficult or Delayed Positioning	2	2
Patient-Device Incompatibility	2	2
Separation Failure	2	2
Difficult to Remove	2	2
Contamination	2	2
Component or Accessory Incompatibility	2	2
Device Damaged Prior to Use	1	1
Material Integrity Problem	1	1
Incomplete or Missing Packaging	1	1
Unsealed Device Packaging	1	1
Defective Component	1	1
Failure To Adhere Or Bond	1	1
Device Difficult to Setup or Prepare	1	1
Failure to Align	1	1

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
Pain	110	110
No Code Available	93	93
Joint Dislocation	89	89
No Information	67	67
Unspecified Infection	56	56
No Known Impact Or Consequence To Patient	40	40
Loss of Range of Motion	38	38
Joint Laxity	34	34
Implant Pain	24	24
Failure of Implant	19	19
No Consequences Or Impact To Patient	18	18
Bone Fracture(s)	18	18
Insufficient Information	17	17
Limited Mobility Of The Implanted Joint	11	11
Fall	10	10
Reaction	9	9
Foreign Body In Patient	8	8
Tissue Damage	6	6
Limb Fracture	6	6
Foreign Body Reaction	5	5
Ambulation Difficulties	4	4
No Clinical Signs, Symptoms or Conditions	4	4
Scar Tissue	4	4
Sleep Dysfunction	3	3
Tissue Breakdown	3	3
Bacterial Infection	3	3
Erosion	3	3
Hematoma	3	3
Injury	3	3
Paralysis	3	3
Numbness	3	3
No Patient Involvement	3	3
Swelling	3	3
Device Embedded In Tissue or Plaque	2	2
Headache	2	2
Muscle/Tendon Damage	2	2
Abscess	2	2
Nerve Damage	2	2
Fever	2	2
Weakness	2	2
Inflammation	2	2
Metal Related Pathology	2	2
Arthralgia	2	2
Muscular Rigidity	1	1
Burn(s)	1	1
Discomfort	1	1
Confusion/ Disorientation	1	1
Rupture	1	1
Hyperextension	1	1
Perforation	1	1