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
Patient Device Interaction Problem	18	18
Loosening of Implant Not Related to Bone-Ingrowth	18	18
Adverse Event Without Identified Device or Use Problem	17	17
Appropriate Term/Code Not Available	16	16
Loose or Intermittent Connection	13	13
Break	10	10
Degraded	6	6
Insufficient Information	6	6
Device Dislodged or Dislocated	5	5
Patient-Device Incompatibility	3	3
Use of Device Problem	2	2
Biocompatibility	2	2
Output Problem	2	2
Positioning Problem	2	2
Material Fragmentation	1	1
Positioning Failure	1	1
Inadequacy of Device Shape and/or Size	1	1
Noise, Audible	1	1
Device-Device Incompatibility	1	1
Fitting Problem	1	1
Failure to Advance	1	1
Physical Resistance/Sticking	1	1

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
Pain	27	27
Failure of Implant	25	25
Insufficient Information	13	13
No Clinical Signs, Symptoms or Conditions	10	10
No Code Available	7	7
Hypersensitivity/Allergic reaction	6	6
Loss of Range of Motion	6	6
Metal Related Pathology	5	5
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available	4	4
Abrasion	4	4
No Known Impact Or Consequence To Patient	3	3
Osteolysis	3	3
Joint Dislocation	2	2
Unspecified Tissue Injury	2	2
Unspecified Infection	1	1
Limited Mobility Of The Implanted Joint	1	1
Implant Pain	1	1
Abscess	1	1
Tissue Damage	1	1
Bacterial Infection	1	1