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	37	37
Loosening of Implant Not Related to Bone-Ingrowth	23	23
Break	9	9
Positioning Failure	8	8
Device Dislodged or Dislocated	6	6
Adverse Event Without Identified Device or Use Problem	3	3
Degraded	2	2
Insufficient Device Problem Information	2	2
Biocompatibility	2	2
Fitting Problem	1	1
Material Fragmentation	1	1
Failure to Advance	1	1

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
Failure of Implant	39	39
Pain	23	23
Insufficient Information	21	21
No Clinical Signs, Symptoms or Conditions	13	13
Metal Related Pathology	11	11
Hypersensitivity/Allergic reaction	7	7
Loss of Range of Motion	4	4
Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available	4	4
Rupture	3	3
Subluxation	3	3
Erosion	3	3
Unspecified Infection	2	2
Osteolysis	2	2
Unspecified Tissue Injury	2	2
Muscle Weakness/Atrophy	1	1
Aseptic loosening	1	1
Joint Dislocation	1	1
Implant Pain	1	1
Medical device site infection	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