TPLC - Total Product Life Cycle

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Device	total shoulder arthroplasty system
Regulation Description	Shoulder joint metal/polymer semi-constrained cemented prosthesis.
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	29	29
Loosening of Implant Not Related to Bone-Ingrowth	26	26
Break	11	11
Adverse Event Without Identified Device or Use Problem	11	11
Positioning Failure	8	8
Appropriate Term/Code Not Available	8	8
Device Dislodged or Dislocated	7	7
Loose or Intermittent Connection	7	7
Insufficient Information	6	6
Degraded	6	6
Output Problem	2	2
Positioning Problem	2	2
Material Fragmentation	2	2
Biocompatibility	2	2
Fitting Problem	1	1
Device-Device Incompatibility	1	1
Patient-Device Incompatibility	1	1
Use of Device Problem	1	1
Inadequacy of Device Shape and/or Size	1	1
Failure to Advance	1	1
Noise, Audible	1	1

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
Failure of Implant	39	39
Pain	22	22
Insufficient Information	16	16
No Clinical Signs, Symptoms or Conditions	13	13
Metal Related Pathology	11	11
Hypersensitivity/Allergic reaction	7	7
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available	4	4
Loss of Range of Motion	4	4
Rupture	3	3
Osteolysis	2	2
Unspecified Tissue Injury	2	2
Unspecified Infection	1	1
Joint Dislocation	1	1
Implant Pain	1	1
Foreign Body Reaction	1	1
Swelling/ Edema	1	1

Recalls
Manufacturer		Recall Class	Date Posted
1	Onkos Surgical, Inc.	II	Jun-27-2025