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	28	28

Device Problems	MDRs with this Device Problem	Events in those MDRs
Insufficient Information	115	115
Adverse Event Without Identified Device or Use Problem	110	110
Device Dislodged or Dislocated	89	89
Fracture	83	83
Difficult to Insert	40	40
Unstable	38	38
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
Device Operates Differently Than Expected	8	8
Device-Device Incompatibility	8	8
Naturally Worn	8	8
Detachment of Device or Device Component	6	6
Device Damaged by Another Device	5	5
Malposition of Device	5	5
Noise, Audible	5	5
Disassembly	5	5
Material Erosion	5	5
Loose or Intermittent Connection	5	5
Mechanical Problem	4	4
Bent	4	4
Break	4	4
No Apparent Adverse Event	4	4
Loosening of Implant Not Related to Bone-Ingrowth	3	3
Packaging Problem	3	3
Device Slipped	3	3
Metal Shedding Debris	3	3
Separation Failure	2	2
Off-Label Use	2	2
Difficult to Remove	2	2
Material Separation	2	2
Inadequacy of Device Shape and/or Size	2	2
Contamination	2	2
Difficult or Delayed Positioning	2	2
Positioning Failure	2	2
Positioning Problem	2	2
Material Deformation	2	2
Patient-Device Incompatibility	2	2
Component or Accessory Incompatibility	2	2
Migration	2	2
Material Split, Cut or Torn	1	1
Patient Device Interaction Problem	1	1
Device Operational Issue	1	1
Compatibility Problem	1	1
Material Integrity Problem	1	1
Mechanical Jam	1	1
Scratched Material	1	1
Temperature Problem	1	1
Misassembled	1	1
Delivered as Unsterile Product	1	1
Device Emits Odor	1	1
Unsealed Device Packaging	1	1
Sticking	1	1
Device Difficult to Setup or Prepare	1	1
Failure To Adhere Or Bond	1	1
Device Damaged Prior to Use	1	1
Defective Component	1	1
Incomplete or Missing Packaging	1	1
Failure to Align	1	1

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
Pain	108	108
No Code Available	93	93
Joint Dislocation	85	85
No Information	67	67
Unspecified Infection	51	51
No Known Impact Or Consequence To Patient	40	40
Loss of Range of Motion	38	38
Joint Laxity	29	29
Implant Pain	18	18
No Consequences Or Impact To Patient	18	18
Bone Fracture(s)	18	18
Failure of Implant	17	17
Insufficient Information	11	11
Limited Mobility Of The Implanted Joint	11	11
Fall	10	10
Reaction	9	9
Foreign Body In Patient	7	7
Limb Fracture	6	6
Tissue Damage	6	6
Foreign Body Reaction	5	5
Scar Tissue	4	4
Ambulation Difficulties	4	4
Tissue Breakdown	3	3
No Patient Involvement	3	3
Swelling	3	3
Numbness	3	3
Sleep Dysfunction	3	3
Injury	3	3
Bacterial Infection	3	3
Erosion	3	3
Hematoma	3	3
Paralysis	3	3
Inflammation	2	2
Headache	2	2
Abscess	2	2
Weakness	2	2
Device Embedded In Tissue or Plaque	2	2
Nerve Damage	2	2
Arthralgia	2	2
No Clinical Signs, Symptoms or Conditions	2	2
Metal Related Pathology	2	2
Muscle/Tendon Damage	2	2
Confusion/ Disorientation	1	1
Patient Problem/Medical Problem	1	1
Not Applicable	1	1
Hyperextension	1	1
Subluxation	1	1
Dizziness	1	1
Fracture, Arm	1	1
Urinary Tract Infection	1	1
Rupture	1	1
Urinary Frequency	1	1
Discomfort	1	1
Complaint, Ill-Defined	1	1
Toxicity	1	1
Fever	1	1
Burn(s)	1	1
Stroke/CVA	1	1
Cyst(s)	1	1
Death	1	1
Muscular Rigidity	1	1
Perforation	1	1

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