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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: SMITH & NEPHEW, INC. HIP IMPLANT; PROSTHESIS, HIP, HEMI-, TRUNNION-BEARING, FEMORAL, METAL/POLYACETAL
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SMITH & NEPHEW, INC. HIP IMPLANT; PROSTHESIS, HIP, HEMI-, TRUNNION-BEARING, FEMORAL, METAL/POLYACETAL Back to Search Results
Device Problem Fitting Problem (2183)
Patient Problem Injury (2348)
Event Date 01/23/2019
Event Type  Injury  
Event Description
It was reported that revision surgery was performed for a hip device, with a swap out of liner.During case, the explant sizes were compared, the size matched the reflection xlpe f based on trial liners.Upon impacting the new liner, the liner would not sit properly.An alternate insert was opened and cemented into the existing cup.
 
Manufacturer Narrative
The associated complaint device was not returned for evaluation.Our clinical/medical team noted: no relevant clinical medical information was provided to conduct a thorough medical assessment.Without the actual product involved and/or device information, our investigation cannot proceed.If the device or new information is received in the future, this complaint can be re-opened.No further actions are being taken at this time.We consider this investigation closed.
 
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Brand Name
HIP IMPLANT
Type of Device
PROSTHESIS, HIP, HEMI-, TRUNNION-BEARING, FEMORAL, METAL/POLYACETAL
Manufacturer (Section D)
SMITH & NEPHEW, INC.
1450 brooks road
memphis TN 38116
MDR Report Key8346412
MDR Text Key136442994
Report Number1020279-2019-00598
Device Sequence Number1
Product Code JDH
Combination Product (y/n)N
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,health
Type of Report Initial,Followup
Report Date 09/09/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received02/16/2019
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator Health Professional
Date Manufacturer Received01/23/2019
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Patient Outcome(s) Hospitalization; Required Intervention;
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