TPLC - Total Product Life Cycle

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Device Problems	MDRs with this Device Problem	Events in those MDRs
Break	325	325
Adverse Event Without Identified Device or Use Problem	239	243
Detachment of Device or Device Component	101	101
Fracture	65	65
Device-Device Incompatibility	31	31
Device Dislodged or Dislocated	31	31
Migration	31	34
Manufacturing, Packaging or Shipping Problem	28	28
Physical Resistance/Sticking	25	25
Difficult to Advance	22	22
Crack	20	20
Patient Device Interaction Problem	14	14
Appropriate Term/Code Not Available	13	13
Loosening of Implant Not Related to Bone-Ingrowth	12	12
Entrapment of Device	9	9
Material Deformation	9	9
Migration or Expulsion of Device	8	8
Material Separation	7	7
Insufficient Information	7	7
Material Twisted/Bent	6	6
Material Fragmentation	6	6
Material Split, Cut or Torn	5	5
Loose or Intermittent Connection	4	4
Inaccurate Information	4	4
No Apparent Adverse Event	4	4
Mechanical Jam	3	3
Corroded	3	3
Connection Problem	3	3
Packaging Problem	3	3
Difficult to Remove	3	3
Device Contaminated During Manufacture or Shipping	3	3
Unintended Movement	3	3
Patient-Device Incompatibility	3	3
Fitting Problem	2	2
Component Missing	2	2
Failure to Align	2	2
Flaked	2	2
Firing Problem	2	2
Failure to Cut	2	2
Device Damaged by Another Device	2	2
Material Integrity Problem	2	2
Defective Component	2	2
Failure to Form Staple	2	2
Mechanical Problem	2	2
Device Damaged Prior to Use	2	2
Activation Problem	2	2
Failure to Advance	2	2
Failure to Eject	2	2
Loss of Osseointegration	1	1
Deformation Due to Compressive Stress	1	1

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
No Clinical Signs, Symptoms or Conditions	502	502
Pain	76	76
Non-union Bone Fracture	72	72
Insufficient Information	56	56
No Consequences Or Impact To Patient	48	48
Failure of Implant	39	39
Injury	38	38
No Code Available	31	31
Unspecified Tissue Injury	26	26
Foreign Body In Patient	23	23
Bone Fracture(s)	20	20
Post Operative Wound Infection	19	19
Hypersensitivity/Allergic reaction	16	16
Perforation	16	16
Impaired Healing	14	14
No Known Impact Or Consequence To Patient	14	14
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available	12	12
Tissue Damage	12	12
Loss of Range of Motion	12	15
Implant Pain	12	16
Unspecified Infection	11	11
Not Applicable	11	11
Discomfort	11	11
Skin Inflammation/ Irritation	10	10
No Patient Involvement	8	8
Wound Dehiscence	7	7
No Information	7	7
Malunion of Bone	6	6
Swelling/ Edema	5	5
Foreign Body Reaction	5	5
Cellulitis	5	5
Device Embedded In Tissue or Plaque	4	4
Abscess	4	4
Cyst(s)	4	4
Rupture	4	4
Osteolysis	3	3
Fall	3	3
Skin Infection	3	3
Arthritis	3	3
Synovitis	3	3
Muscular Rigidity	2	2
Swelling	2	2
Numbness	2	2
Nerve Damage	2	2
Joint Dislocation	2	2
Unspecified Musculoskeletal problem	2	2
Muscle/Tendon Damage	2	2
Stroke/CVA	2	2
Inflammation	2	2
Physical Asymmetry	2	2

Recalls
Manufacturer		Recall Class	Date Posted
1	Biomet, Inc.	II	Mar-18-2022
2	Merete Medical GmbH	II	Feb-17-2022
3	Stryker GmbH	II	Nov-16-2020
4	Synthes (USA) Products LLC	II	Oct-18-2022
5	Synthes (USA) Products LLC	II	Oct-06-2022
6	Wright Medical Technology, Inc.	II	Mar-31-2022