TPLC - Total Product Life Cycle

• Device: prosthesis, shoulder, semi-constrained, metal/polymer + additive, cemented
• Definition: Total shoulders are indicated for arthritis (osteo-, rheumatoid, traumatic), avascular necrosis, correction of functional deformity, and revision procedures.
• Product Code: PAO
• Regulation Number: 888.3660
• Device Class: 2

Premarket Reviews
Manufacturer	Decision
TORNIER, INC.
	SUBSTANTIALLY EQUIVALENT	1

MDR Year	MDR Reports	MDR Events
2014	30	30
2015	55	55
2016	63	63
2017	176	176
2018	93	93
2019	17	17
2020	7	7
2021	7	7
2022	9	9
2023	65	65
2024	15	15

Device Problems	MDRs with this Device Problem	Events in those MDRs
Insufficient Information	115	115
Adverse Event Without Identified Device or Use Problem	99	99
Device Dislodged or Dislocated	89	89
Fracture	83	83
Difficult to Insert	40	40
Unstable	37	37
Migration or Expulsion of Device	20	20
Appropriate Term/Code Not Available	17	17
Detachment Of Device Component	11	11
Fitting Problem	10	10
Difficult To Position	9	9
Naturally Worn	8	8
Device-Device Incompatibility	8	8
Device Operates Differently Than Expected	8	8
Detachment of Device or Device Component	6	6
Noise, Audible	5	5
Material Erosion	5	5
Malposition of Device	5	5
Loose or Intermittent Connection	5	5
Device Damaged by Another Device	5	5
Disassembly	5	5
Bent	4	4
Break	4	4
Mechanical Problem	4	4
Device Slipped	3	3
Packaging Problem	3	3
Loosening of Implant Not Related to Bone-Ingrowth	3	3
No Apparent Adverse Event	3	3
Metal Shedding Debris	3	3
Difficult or Delayed Positioning	2	2
Difficult to Remove	2	2
Patient-Device Incompatibility	2	2
Contamination	2	2
Material Separation	2	2
Separation Failure	2	2
Off-Label Use	2	2
Component or Accessory Incompatibility	2	2
Material Deformation	2	2
Inadequacy of Device Shape and/or Size	2	2
Positioning Problem	2	2
Scratched Material	1	1
Device Damaged Prior to Use	1	1
Temperature Problem	1	1
Failure to Align	1	1
Sticking	1	1
Device Emits Odor	1	1
Incomplete or Missing Packaging	1	1
Positioning Failure	1	1
Patient Device Interaction Problem	1	1
Mechanical Jam	1	1
Unsealed Device Packaging	1	1
Defective Component	1	1
Failure To Adhere Or Bond	1	1
Compatibility Problem	1	1
Migration	1	1
Material Integrity Problem	1	1
Device Operational Issue	1	1
Misassembled	1	1
Delivered as Unsterile Product	1	1
Material Split, Cut or Torn	1	1

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
Pain	108	108
No Code Available	93	93
Joint Dislocation	84	84
No Information	67	67
Unspecified Infection	50	50
No Known Impact Or Consequence To Patient	40	40
Loss of Range of Motion	37	37
Joint Laxity	23	23
Bone Fracture(s)	18	18
No Consequences Or Impact To Patient	18	18
Failure of Implant	17	17
Implant Pain	17	17
Limited Mobility Of The Implanted Joint	11	11
Fall	10	10
Insufficient Information	9	9
Reaction	9	9
Foreign Body In Patient	7	7
Tissue Damage	6	6
Foreign Body Reaction	5	5
Limb Fracture	5	5
Scar Tissue	4	4
Ambulation Difficulties	4	4
Numbness	3	3
Injury	3	3
Paralysis	3	3
Hematoma	3	3
Erosion	3	3
Bacterial Infection	3	3
Tissue Breakdown	3	3
No Patient Involvement	3	3
Sleep Dysfunction	3	3
Swelling	3	3
Inflammation	2	2
Arthralgia	2	2
Weakness	2	2
Device Embedded In Tissue or Plaque	2	2
Nerve Damage	2	2
Headache	2	2
Abscess	2	2
Metal Related Pathology	2	2
Toxicity	1	1
Perforation	1	1
Fever	1	1
Fracture, Arm	1	1
Rupture	1	1
Dizziness	1	1
Discomfort	1	1
Patient Problem/Medical Problem	1	1
Urinary Tract Infection	1	1
Urinary Frequency	1	1
Complaint, Ill-Defined	1	1
No Clinical Signs, Symptoms or Conditions	1	1
Muscle/Tendon Damage	1	1
Death	1	1
Not Applicable	1	1
Stroke/CVA	1	1
Muscular Rigidity	1	1
Confusion/ Disorientation	1	1
Subluxation	1	1
Burn(s)	1	1
Cyst(s)	1	1

Recalls
Manufacturer		Recall Class	Date Posted
1	Biomet, Inc.	II	Jun-17-2013
2	Zimmer Biomet, Inc.	I	Feb-11-2017