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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: SMITH & NEPHEW, INC. R3 36MM ID INTL DLT CER LNR 58MM PROST, HIP, SEMI-CNSTRND, UNCMNTD, MET/POLY, POROUS

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SMITH & NEPHEW, INC. R3 36MM ID INTL DLT CER LNR 58MM PROST, HIP, SEMI-CNSTRND, UNCMNTD, MET/POLY, POROUS Back to Search Results
Catalog Number 71331758
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problem Subluxation (4525)
Event Date 12/10/2021
Event Type  malfunction  
Manufacturer Narrative
Internal reference number: case-(b)(4).
 
Event Description
It was reported that, after a left thr surgery performed on the (b)(6) 2021 via posterior approach with anthology/r3 conc construct, the patient had dislocated hip at rehab post-op. The patient had a revision left thr surgery on (b)(6) 2021 to treat this adverse event. The components seemed well fixed and in appropriate position by surgeon. The patient was dislocating during flexion and ir during rom test. The biolox delta head 36 mm 12/14 s / +0 was removed with punch and the r3 36mm id intl dlt cer lnr 58mm was removed with a liner removal tool. The patient was trialed with 36mm heads and 36x58/20 degree liner trials and the hip seemed stable in rom. 20 degree xlpe liner inserted and impacted into r3 shell, and 36mm l biolox option head impacted to retained anthology stem. The hip was stable through rom. The wound was irrigated and closed in layers. The patient was not harmed beyond the reported problem.
 
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Brand NameR3 36MM ID INTL DLT CER LNR 58MM
Type of DevicePROST, HIP, SEMI-CNSTRND, UNCMNTD, MET/POLY, 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 Key13111724
MDR Text Key282918513
Report Number1020279-2021-08952
Device Sequence Number1
Product Code MBL
Combination Product (y/n)N
Reporter Country CodeAS
PMA/PMN Number
EXEMPT
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Other,Foreign,Health Professional,User Facility,Company Representative
Reporter Occupation
Type of Report Initial,Followup
Report Date 01/31/2022
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received12/29/2021
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Catalogue Number71331758
Device Lot Number17GT90111
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Date Manufacturer Received01/28/2022
Was Device Evaluated by Manufacturer? No Answer Provided
Date Device Manufactured07/17/2017
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage

Patient Treatment Data
Date Received: 12/29/2021 Patient Sequence Number: 1
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