TPLC - Total Product Life Cycle

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Device Problems	MDRs with this Device Problem	Events in those MDRs
Break	249	249
Device-Device Incompatibility	170	170
Contamination /Decontamination Problem	40	40
Fracture	30	30
Entrapment of Device	15	15
Adverse Event Without Identified Device or Use Problem	8	8
Crack	7	7
Material Fragmentation	6	6
Failure to Cut	6	6
Material Integrity Problem	5	5
Material Twisted/Bent	4	4
Mechanical Jam	4	4
Appropriate Term/Code Not Available	3	3
Device Handling Problem	3	3
Use of Device Problem	3	3
Dull, Blunt	3	3
Difficult to Remove	2	2
Material Split, Cut or Torn	2	2
No Apparent Adverse Event	2	2
Naturally Worn	2	2
Material Deformation	2	2
Detachment of Device or Device Component	2	2
Physical Resistance/Sticking	1	1
Migration	1	1
Device Difficult to Maintain	1	1
Material Separation	1	1
Device Slipped	1	1
Difficult to Insert	1	1
Corroded	1	1
Separation Failure	1	1
Fitting Problem	1	1
Expulsion	1	1
Device Contamination with Chemical or Other Material	1	1
Compatibility Problem	1	1
Device Contaminated During Manufacture or Shipping	1	1

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
No Clinical Signs, Symptoms or Conditions	309	309
No Consequences Or Impact To Patient	114	114
No Patient Involvement	57	57
Foreign Body In Patient	28	28
Insufficient Information	15	15
No Known Impact Or Consequence To Patient	12	12
No Code Available	10	10
Injury	5	5
Bone Fracture(s)	3	3
Pain	3	3
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available	2	2
Device Embedded In Tissue or Plaque	2	2
Unspecified Infection	1	1
Patient Problem/Medical Problem	1	1
Not Applicable	1	1
Post Operative Wound Infection	1	1
Nerve Damage	1	1

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