TPLC - Total Product Life Cycle

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Device	total shoulder arthroplasty system
Definition	To treat pain and lack of function in the shoulder.
Product Code	QHQ
Regulation Number	888.3660
Device Class	2

Device Problems	MDRs with this Device Problem	Events in those MDRs
Adverse Event Without Identified Device or Use Problem	17	17
Appropriate Term/Code Not Available	16	16
Loosening of Implant Not Related to Bone-Ingrowth	16	16
Loose or Intermittent Connection	13	13
Break	7	7
Patient Device Interaction Problem	7	7
Insufficient Information	5	5
Device Dislodged or Dislocated	5	5
Degraded	4	4
Patient-Device Incompatibility	3	3
Biocompatibility	2	2
Use of Device Problem	2	2
Output Problem	2	2
Positioning Problem	2	2
Noise, Audible	1	1
Physical Resistance/Sticking	1	1
Device-Device Incompatibility	1	1
Material Fragmentation	1	1
Inadequacy of Device Shape and/or Size	1	1

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
Failure of Implant	21	21
Pain	21	21
Insufficient Information	13	13
No Code Available	7	7
Loss of Range of Motion	6	6
Hypersensitivity/Allergic reaction	6	6
No Clinical Signs, Symptoms or Conditions	5	5
Abrasion	4	4
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available	4	4
Osteolysis	3	3
No Known Impact Or Consequence To Patient	3	3
Unspecified Tissue Injury	2	2
Joint Dislocation	2	2
Tissue Damage	1	1
Abscess	1	1
Bacterial Infection	1	1
Unspecified Infection	1	1
Implant Pain	1	1
Limited Mobility Of The Implanted Joint	1	1
Metal Related Pathology	1	1