TPLC - Total Product Life Cycle

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Device Problems	MDRs with this Device Problem	Events in those MDRs
Break	1230	1237
Degraded	207	207
Material Deformation	187	189
Detachment of Device or Device Component	172	172
Mechanical Jam	133	133
Material Twisted/Bent	115	115
Difficult to Open or Close	94	94
Material Separation	87	87
Device Damaged by Another Device	77	77
Fracture	70	71
Device-Device Incompatibility	69	69
Device Contaminated During Manufacture or Shipping	67	67
Use of Device Problem	53	53
Material Fragmentation	52	52
Dull, Blunt	39	39
Adverse Event Without Identified Device or Use Problem	28	28
Physical Resistance/Sticking	26	26
Corroded	24	24
Flaked	23	23
Defective Device	21	21
Appropriate Term/Code Not Available	18	18
Component Missing	17	17
Insufficient Information	17	18
Mechanical Problem	15	15
Leak/Splash	14	14
Contamination /Decontamination Problem	13	13
Failure to Advance	12	12
Delivered as Unsterile Product	11	11
Sharp Edges	11	11
Material Split, Cut or Torn	11	11
Material Integrity Problem	11	11
Crack	11	11
Device Dislodged or Dislocated	11	11
Failure to Cut	10	10
Device Markings/Labelling Problem	10	10
Packaging Problem	8	8
Loose or Intermittent Connection	8	8
Positioning Failure	8	9
Scratched Material	8	8
Device Damaged Prior to Use	7	7
Firing Problem	7	7
Display or Visual Feedback Problem	6	6
Connection Problem	5	5
Difficult to Remove	5	5
Failure to Cycle	5	5
Illegible Information	5	5
Entrapment of Device	5	5
Naturally Worn	4	4
Material Discolored	4	4
Device Contamination with Chemical or Other Material	4	4

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
No Clinical Signs, Symptoms or Conditions	2189	2196
Insufficient Information	179	179
Foreign Body In Patient	145	147
No Known Impact Or Consequence To Patient	82	82
No Consequences Or Impact To Patient	79	79
No Information	44	44
No Patient Involvement	29	29
Device Embedded In Tissue or Plaque	21	21
Injury	12	12
No Code Available	11	11
Pain	11	11
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available	6	6
Failure of Implant	6	6
Perforation	6	6
Tissue Damage	6	6
Not Applicable	5	5
Laceration(s)	5	5
Extravasation	4	4
Unspecified Tissue Injury	4	4
Rupture	3	3
Swelling/ Edema	3	3
Hypersensitivity/Allergic reaction	2	2
Nerve Damage	2	2
Scar Tissue	2	2
Unspecified Infection	1	1
Neuropathy	1	1
Joint Dislocation	1	1
Sepsis	1	1
Inadequate Osseointegration	1	1
Unspecified Musculoskeletal problem	1	1
Itching Sensation	1	1
Post Operative Wound Infection	1	1
Paresthesia	1	1
Burning Sensation	1	1
Loss of Range of Motion	1	1
Numbness	1	1
Capsular Contracture	1	1
Joint Laxity	1	1
Distress	1	1

Recalls
Manufacturer		Recall Class	Date Posted
1	Smith & Nephew, Inc.	II	Oct-27-2020