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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: SMITH & NEPHEW, INC. 56MM AND R3 ACETABULAR SHELL; PROSTHESIS, HIP, SEMI-CONSTRAINED METAL/POLYMER, POROUS UNCEMENTED
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SMITH & NEPHEW, INC. 56MM AND R3 ACETABULAR SHELL; PROSTHESIS, HIP, SEMI-CONSTRAINED METAL/POLYMER, POROUS UNCEMENTED Back to Search Results
Catalog Number 7133-5556
Device Problem Loose or Intermittent Connection (1371)
Patient Problems Unspecified Infection (1930); Pain (1994); Thyroid Problems (2102); Ambulation Difficulties (2544)
Event Date 10/20/2016
Event Type  Injury  
Event Description
I underwent a total hip arthroplasty on my left hip on (b)(6) 2011.The implant was all smith & nephew components in a metal-on-metal configuration, including the following components: smiths & nephew 56mm r3 acetabular shell (ref no.(b)(4), k092386), r3 cocr metal liner (ref no.(b)(4), p040033 s006), and cocr modular femoral (hemi) head (ref no.(b)(4), k062408).On (b)(6) 2016, i had a revision surgery of the left hip.The head and cup were removed and replaced.I was diagnosed with "left hip mechanical loosening." the dr who checked the infection in my hip had never seen so much infected fluid buildup before an entire syringe full of fluid.Severe hip pain before revision surgery, unable to handle manual transmission on semi truck.Occasional pain, cannot run or jog hypo-thyroidism; 7412-2544 head, lot no.09aw21331 liner 07hw13127 head, udi no (b)(4) liner; +(b)(4) head.
 
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Brand Name
56MM AND R3 ACETABULAR SHELL
Type of Device
PROSTHESIS, HIP, SEMI-CONSTRAINED METAL/POLYMER, POROUS UNCEMENTED
Manufacturer (Section D)
SMITH & NEPHEW, INC.
MDR Report Key7880553
MDR Text Key120539177
Report NumberMW5079817
Device Sequence Number1
Product Code MBL
Combination Product (y/n)N
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Voluntary
Reporter Occupation Other
Type of Report Initial
Report Date 08/27/2018
3 Devices were Involved in the Event: 1   2   3  
1 Patient was Involved in the Event
Date FDA Received09/14/2018
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator No Information
Device Catalogue Number7133-5556
Was Device Evaluated by Manufacturer? No Information
Type of Device Usage N
Patient Sequence Number1
Patient Outcome(s) Hospitalization; Required Intervention; Disability;
Patient Age54 YR
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