TPLC - Total Product Life Cycle

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Device Problems	MDRs with this Device Problem	Events in those MDRs
Break	232	232
Device-Device Incompatibility	141	141
Contamination /Decontamination Problem	36	36
Fracture	14	14
Entrapment of Device	11	11
Material Fragmentation	9	9
Crack	6	6
Failure to Cut	6	6
Adverse Event Without Identified Device or Use Problem	6	6
Device Contamination with Chemical or Other Material	4	4
Material Integrity Problem	4	4
Material Twisted/Bent	3	3
Mechanical Jam	3	3
Appropriate Term/Code Not Available	3	3
Device Handling Problem	3	3
Dull, Blunt	3	3
Use of Device Problem	3	3
Detachment of Device or Device Component	2	2
Material Split, Cut or Torn	2	2
Naturally Worn	2	2
Compatibility Problem	1	1
Device Contaminated During Manufacture or Shipping	1	1
Device Difficult to Maintain	1	1
No Apparent Adverse Event	1	1
Physical Resistance/Sticking	1	1
Migration	1	1
Expulsion	1	1
Fitting Problem	1	1
Device Or Device Fragments Location Unknown	1	1
Patient-Device Incompatibility	1	1
Detachment Of Device Component	1	1
Corroded	1	1
Difficult to Insert	1	1
Material Puncture/Hole	1	1
Difficult to Remove	1	1
Material Separation	1	1
Device Slipped	1	1

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
No Clinical Signs, Symptoms or Conditions	212	212
No Consequences Or Impact To Patient	127	127
No Patient Involvement	78	78
Foreign Body In Patient	25	25
No Known Impact Or Consequence To Patient	22	22
No Code Available	11	11
Injury	5	5
Device Embedded In Tissue or Plaque	3	3
Insufficient Information	3	3
Pain	3	3
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available	2	2
Not Applicable	1	1
Patient Problem/Medical Problem	1	1
Post Operative Wound Infection	1	1
Bone Fracture(s)	1	1
Unspecified Infection	1	1
Nerve Damage	1	1

Recalls
Manufacturer		Recall Class	Date Posted
1	Zimmer GmbH	II	May-23-2019