TPLC - Total Product Life Cycle

• Device: prosthesis, hip, semi-constrained, metal/ceramic/polymer, cemented or non-porous, uncemented
• Regulation Description: Hip joint metal/ceramic/polymer semi-constrained cemented or nonporous uncemented prosthesis.
• Product Code: LZO
• Regulation Number: 888.3353
• Device Class: 2

Premarket Reviews
Manufacturer	Decision
B-ONE ORTHO, CORP.
	SUBSTANTIALLY EQUIVALENT	2
BIOMET ORTHOPEDICS
	SUBSTANTIALLY EQUIVALENT	1
BIOMET UK, LTD.
	SUBSTANTIALLY EQUIVALENT	2
CORENTEC CO., LTD.
	SUBSTANTIALLY EQUIVALENT	1
CORIN U.S.A. LIMITED
	SUBSTANTIALLY EQUIVALENT	2
CORIN USA
	SUBSTANTIALLY EQUIVALENT	1
CORIN, LTD.
	SUBSTANTIALLY EQUIVALENT	1
DEPUY IRELAND UC
	SUBSTANTIALLY EQUIVALENT	6
DEPUY ORTHOPAEDICS, INC.
	SUBSTANTIALLY EQUIVALENT	2
ENCORE MEDICAL, LP
	SUBSTANTIALLY EQUIVALENT	1
EXACTECH, INC.
	SUBSTANTIALLY EQUIVALENT	1
HOWMEDICA OSTEONICS CORP., DBA STRYKER ORTHOPAEDICS
	SUBSTANTIALLY EQUIVALENT	3
IMPLANTCAST, GMBH
	SUBSTANTIALLY EQUIVALENT	6
KYOCERA CORPORATION
	SUBSTANTIALLY EQUIVALENT	1
LIMA CORPORATE S.P.A.
	SUBSTANTIALLY EQUIVALENT	1
LIMACORPORATE
	SUBSTANTIALLY EQUIVALENT	1
MEDACTA INTERNATIONAL SA
	SUBSTANTIALLY EQUIVALENT	13
MICROPORT ORTHOPEDICS, INC.
	SUBSTANTIALLY EQUIVALENT	3
ORCHARD MEDICAL DEVELOPMENT
	SUBSTANTIALLY EQUIVALENT	1
ORCHARD MEDICAL DEVELOPMENT, LLC
	SUBSTANTIALLY EQUIVALENT	1
SERF
	SUBSTANTIALLY EQUIVALENT	1
SIGNATURE ORTHOPAEDICS PTY, LTD.
	SUBSTANTIALLY EQUIVALENT	7
SMITH & NEPHEW, INC.
	SUBSTANTIALLY EQUIVALENT	4
TOTAL JOINT ORTHOPEDICS, INC.
	SUBSTANTIALLY EQUIVALENT	1
TOTAL JOINT OTHOPEDICS, INC.
	SUBSTANTIALLY EQUIVALENT	1
UNITED ORTHOPEDIC CORPORATION
	SUBSTANTIALLY EQUIVALENT	3
WALDEMAR LINK GMBH & CO KG
	SUBSTANTIALLY EQUIVALENT	4
XERXES ARTHOPEDIX, LLC
	SUBSTANTIALLY EQUIVALENT	1
ZIMMER BIOMET
	SUBSTANTIALLY EQUIVALENT	1
ZIMMER GMBH
	SUBSTANTIALLY EQUIVALENT	1
ZIMMER, INC.
	SUBSTANTIALLY EQUIVALENT	2

MDR Year	MDR Reports	MDR Events
2020	1963	1986
2021	2199	2241
2022	1985	2055
2023	2064	2156
2024	2586	2946
2025	2990	4541

Device Problems	MDRs with this Device Problem	Events in those MDRs
Adverse Event Without Identified Device or Use Problem	5411	6280
Device Dislodged or Dislocated	2213	2551
Fracture	1004	1032
Appropriate Term/Code Not Available	802	813
Insufficient Information	701	736
Osseointegration Problem	584	603
Naturally Worn	416	543
Break	312	316
Loosening of Implant Not Related to Bone-Ingrowth	304	476
Material Erosion	297	389
Device Appears to Trigger Rejection	274	276
Migration	258	404
Unstable	177	178
Tear, Rip or Hole in Device Packaging	175	176
Manufacturing, Packaging or Shipping Problem	164	164
Loss of Osseointegration	161	240
Loose or Intermittent Connection	159	159
Noise, Audible	146	158
Patient Device Interaction Problem	132	138
Corroded	127	146
Detachment of Device or Device Component	127	132
Packaging Problem	120	120
Difficult to Insert	114	115
Failure to Osseointegrate	72	72
Delivered as Unsterile Product	70	70
Inadequacy of Device Shape and/or Size	69	69
Degraded	69	72
Malposition of Device	67	102
Use of Device Problem	55	55
Patient-Device Incompatibility	52	52
Device Contaminated During Manufacture or Shipping	51	51
Mechanical Problem	50	51
No Apparent Adverse Event	43	44
Material Integrity Problem	43	47
Crack	42	42
Unintended Movement	42	43
Positioning Problem	32	32
Biocompatibility	31	32
Positioning Failure	29	29
Off-Label Use	28	28
Device-Device Incompatibility	27	27
Improper or Incorrect Procedure or Method	26	26
Migration or Expulsion of Device	26	28
Difficult to Remove	25	27
Scratched Material	23	23
Separation Failure	23	23
Device Damaged Prior to Use	22	22
Mechanical Jam	21	23
Loss of or Failure to Bond	20	21
Inaccurate Information	20	21

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
Unspecified Infection	2310	2428
Joint Dislocation	2259	2631
Pain	2191	2426
No Clinical Signs, Symptoms or Conditions	1601	2024
Insufficient Information	1308	1560
Failure of Implant	1013	1118
Inadequate Osseointegration	717	739
Bone Fracture(s)	680	738
No Code Available	611	616
Joint Laxity	609	636
Metal Related Pathology	480	699
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available	434	441
Fall	373	382
Osteolysis	292	355
Limb Fracture	287	289
Ambulation Difficulties	271	289
Foreign Body Reaction	210	235
Loss of Range of Motion	173	203
Implant Pain	172	202
No Known Impact Or Consequence To Patient	136	137
Swelling/ Edema	134	147
No Information	124	128
Unequal Limb Length	122	125
Inflammation	119	126
Discomfort	118	123
Physical Asymmetry	114	119
Hematoma	104	109
Injury	97	97
Ossification	89	103
Unspecified Tissue Injury	88	95
Hip Fracture	87	91
Hypersensitivity/Allergic reaction	86	99
Scar Tissue	86	97
Fluid Discharge	78	80
Bacterial Infection	78	81
Joint Disorder	76	76
Muscle/Tendon Damage	76	87
Necrosis	76	83
Thrombosis/Thrombus	64	66
Synovitis	62	70
No Consequences Or Impact To Patient	57	57
Wound Dehiscence	51	53
Post Operative Wound Infection	49	97
Hemorrhage/Bleeding	47	54
Subluxation	45	54
Adhesion(s)	45	51
Foreign Body In Patient	42	46
Fatigue	41	46
Local Reaction	41	45
Osteopenia/ Osteoporosis	38	43

Recalls
Manufacturer		Recall Class	Date Posted
1	BioPro, Inc.	II	Oct-14-2025
2	Biomet, Inc.	II	Dec-18-2023
3	Biomet, Inc.	II	May-28-2020
4	Corin Ltd	II	Dec-19-2022
5	Encore Medical, LP	II	Sep-19-2023
6	Exactech, Inc.	II	Sep-09-2022
7	Exactech, Inc.	II	Aug-12-2021
8	Exactech, Inc.	II	Jul-22-2021
9	Howmedica Osteonics Corp.	II	Mar-31-2022
10	IMPLANTCAST GMBH	II	Jul-09-2021
11	OMNIlife science Inc.	II	Jan-26-2021
12	Smith & Nephew Inc	II	May-24-2024
13	Smith & Nephew Orthopaedics AG	II	Aug-19-2020
14	Waldemar Link GmbH & Co. KG (Mfg Site)	II	Dec-26-2024
15	Waldemar Link GmbH & Co. KG (Mfg Site)	II	Feb-29-2024
16	Waldemar Link GmbH & Co. KG (Mfg Site)	II	Aug-04-2023
17	Zimmer GmbH	II	Sep-12-2024
18	Zimmer, Inc.	II	Apr-21-2025
19	Zimmer, Inc.	II	Mar-24-2025