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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: SMITH & NEPHEW, INC. 40MM OXINIUM MODULAR HEAD PROSTHESIS, HIP, SEMI-CONSTRAINED, UNCEMENTED, METAL/POLYMER, POROUS

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SMITH & NEPHEW, INC. 40MM OXINIUM MODULAR HEAD PROSTHESIS, HIP, SEMI-CONSTRAINED, UNCEMENTED, METAL/POLYMER, POROUS Back to Search Results
Model Number 71342340
Device Problems Naturally Worn (2988); Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Failure of Implant (1924); Joint Dislocation (2374); Ambulation Difficulties (2544); Joint Laxity (4526)
Event Date 10/08/2021
Event Type  Injury  
Manufacturer Narrative
Internal complaint reference (b)(4).
 
Event Description
(b)(6). It was reported that, after a first revision surgery was performed on the plaintiff¿s right hip on (b)(6) 2017, the plaintiff experienced instability and a joint dislocation. A revision surgery was performed on (b)(6) 2018 to treat this adverse event. During this procedure, the 40mm oxinium modular head was explanted. A blackened tissue was noticeable intraoperatively due to a significant wear present on this explanted head. The plaintiff¿s outcome is unknown.
 
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Brand Name40MM OXINIUM MODULAR HEAD
Type of DevicePROSTHESIS, HIP, SEMI-CONSTRAINED, UNCEMENTED, METAL/POLYMER, POROUS
Manufacturer (Section D)
SMITH & NEPHEW, INC.
1450 brooks rd.
memphis TN 38116
Manufacturer (Section G)
SMITH & NEPHEW, INC.
1450 brooks rd.
memphis TN 38116
Manufacturer Contact
holly topping
7000 west william cannon drive
austin, TX 78735
5123913905
MDR Report Key12720454
MDR Text Key279056814
Report Number1020279-2021-07727
Device Sequence Number1
Product Code MBL
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K093363
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Health Professional,Company Representative
Reporter Occupation
Type of Report Initial,Followup,Followup
Report Date 01/25/2022
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received10/29/2021
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Model Number71342340
Device Catalogue Number71342340
Device Lot Number17BM11392
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Date Manufacturer Received01/21/2022
Was Device Evaluated by Manufacturer? No
Date Device Manufactured02/15/2017
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

Patient Treatment Data
Date Received: 10/29/2021 Patient Sequence Number: 1
Treatment
71306614-SYN POR FEM COMP SZ 14; 71344248-TITANIUM MODULAR HEAD SLV 12/14 TPR +4
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