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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: SMITH & NEPHEW ORTHOPAEDICS AG SMITH AND NEPHEW FEMORAL TRIAL HEAD PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/CERAMIC/POLYMER, CEMENTED OR NON-POROUS

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SMITH & NEPHEW ORTHOPAEDICS AG SMITH AND NEPHEW FEMORAL TRIAL HEAD PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/CERAMIC/POLYMER, CEMENTED OR NON-POROUS Back to Search Results
Catalog Number UNKNOWN TRIAL FEMORAL HEAD
Device Problem Misassembled
Event Date 08/29/2018
Event Type  Malfunction  
Event Description

It was reported that during trialling the femoral heads on the actual prosthesis, both the -3 global head trial and the s and m plus head trials dissociated from the neck both during the shuck test, as well as the 90deg external rotation stability test. This meant the surgeon could not ascertain the hip stability, requiring an intraoperative x-ray to ascertain leg length and offset. Adding 45 minuets to the operation. The outcome of the patient was positive. No injury was caused.

 
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Brand NameSMITH AND NEPHEW FEMORAL TRIAL HEAD
Type of DevicePROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/CERAMIC/POLYMER, CEMENTED OR NON-POROUS
Manufacturer (Section D)
SMITH & NEPHEW ORTHOPAEDICS AG
oberneuhofstrasse 10d
baar, 06340
SZ  06340
Manufacturer (Section G)
SMITH & NEPHEW ORTHOPAEDICS AG
schachenallee 29
aarau, CH500 0
SZ  CH5000
Manufacturer Contact
sarah freestone
oberneuhofstrasse 10d
baar,  06340
  06340
MDR Report Key7975858
Report Number9613369-2018-00064
Device Sequence Number1
Product CodeLZO
Report Source Manufacturer
Source Type COMPANY REPRESENTATIVE,FOREIG
Reporter Occupation OTHER HEALTH CARE PROFESSIONAL
Type of Report Initial,Followup
Report Date 11/07/2018
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received10/17/2018
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? Yes
Device Operator HEALTH PROFESSIONAL
Device Catalogue NumberUNKNOWN TRIAL FEMORAL HEAD
Device LOT NumberUNKNOWN
Was Device Available For Evaluation? No
Is The Reporter A Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
Is The Device Single Use? No
Is this a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Reuse

Patient TREATMENT DATA
Date Received: 10/17/2018 Patient Sequence Number: 1
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