TPLC - Total Product Life Cycle

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Device Problems	MDRs with this Device Problem	Events in those MDRs
Break	49	49
Mechanical Jam	18	18
Leak/Splash	15	15
Failure to Eject	11	11
Chemical Problem	9	9
Appropriate Term/Code Not Available	8	8
Adverse Event Without Identified Device or Use Problem	7	7
Device-Device Incompatibility	6	6
Mechanics Altered	6	6
Defective Device	5	5
Loss of or Failure to Bond	4	4
Entrapment of Device	3	3
Defective Component	3	3
Connection Problem	2	2
Device Contaminated During Manufacture or Shipping	2	2
Material Deformation	2	2
Material Twisted/Bent	1	1
Manufacturing, Packaging or Shipping Problem	1	1
Output Problem	1	1
Packaging Problem	1	1
Pumping Problem	1	1
Therapeutic or Diagnostic Output Failure	1	1
Naturally Worn	1	1
Explosion	1	1
Malposition of Device	1	1
Expiration Date Error	1	1
Fracture	1	1
Migration or Expulsion of Device	1	1
Failure to Prime	1	1
Off-Label Use	1	1
Difficult to Remove	1	1
Material Separation	1	1
Device Slipped	1	1
Improper or Incorrect Procedure or Method	1	1

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
No Clinical Signs, Symptoms or Conditions	64	64
No Consequences Or Impact To Patient	35	35
Insufficient Information	8	8
Pain	7	7
Extravasation	7	7
No Known Impact Or Consequence To Patient	5	5
Foreign Body In Patient	4	4
No Code Available	4	4
Device Embedded In Tissue or Plaque	3	3
No Patient Involvement	2	2
Abrasion	2	2
Necrosis	2	2
Non-union Bone Fracture	2	2
Spinal Cord Injury	1	1
Paraplegia	1	1
Weight Changes	1	1
Neuropathy	1	1
Synovitis	1	1
Adhesion(s)	1	1
Dysphagia/ Odynophagia	1	1
Edema	1	1
Hair Loss	1	1
Failure of Implant	1	1
Inflammation	1	1
Vertebral Fracture	1	1
Joint Laxity	1	1
Nervous System Injury	1	1

Recalls
Manufacturer		Recall Class	Date Posted
1	Zimmer Biomet, Inc.	II	Apr-01-2019