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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: SMITH & NEPHEW ORTHOPAEDICS LTD BHR ACETABULAR CUP; PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/METAL, RESURFACING
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SMITH & NEPHEW ORTHOPAEDICS LTD BHR ACETABULAR CUP; PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/METAL, RESURFACING Back to Search Results
Device Problems Metal Shedding Debris (1804); Insufficient Information (3190)
Patient Problems Failure of Implant (1924); Pain (1994); Injury (2348); Test Result (2695)
Event Type  Injury  
Event Description
It was reported that right hip revision surgery is scheduled.Bilateral patient, see mdr 3005975929-2018-00187 for left hip revision.Elevated metal ion levels reported.
 
Manufacturer Narrative
It was reported that right hip revision surgery has been scheduled.Elevated metal ions has been reported.As of today, device return and additional information has been requested for this complaint but has not become available.In the absence of the actual devices, the production records were reviewed for the known devices reportedly involved in this incident.Review of manufacturing records did not reveal any waivers, concessions, manufacturing or material abnormalities that could have contributed to this issue.The available medical documents were reviewed.Review of the provided implantation report did not reveal any inconsistencies related to the surgical technique that could explain the revision.No information on the revision was provided.No information on the mentioned blood metal ion concentrations was provided.In conclusion: a thorough investigation cannot be performed.Without return of the actual devices or further information we cannot further investigate or confirm the details supplied in this complaint, and our investigation remains inconclusive.
 
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Brand Name
BHR ACETABULAR CUP
Type of Device
PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/METAL, RESURFACING
Manufacturer (Section D)
SMITH & NEPHEW ORTHOPAEDICS LTD
aurora house
spa park
leamington spa CV31 3HL
UK  CV31 3HL
MDR Report Key7564580
MDR Text Key109894714
Report Number3005975929-2018-00188
Device Sequence Number1
Product Code NXT
Combination Product (y/n)N
PMA/PMN Number
P040033
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type consumer,other
Type of Report Initial,Followup,Followup
Report Date 09/10/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator No Information
Was Device Available for Evaluation? No
Initial Date Manufacturer Received 05/23/2018
Initial Date FDA Received06/04/2018
Supplement Dates Manufacturer Received11/15/2018
11/15/2018
Supplement Dates FDA Received11/29/2018
09/10/2019
Patient Sequence Number1
Treatment
FEMORAL STEM, PART AND LOT # UNKNOWN; HEMI HEAD, 74122554, 08JW18692; HEMI HEAD, PART AND LOT # UNKNOWN; MODULAR SLEEVE, 74222200, 10ET42418; MODULAR SLEEVE, PART AND LOT # UNKNOWN; SYN POR STEM, 71309015, 11BM11660; FEMORAL STEM, PART AND LOT # UNKNOWN; HEMI HEAD, PART AND LOT # UNKNOWN; MODULAR SLEEVE, PART AND LOT # UNKNOWN
Patient Outcome(s) Hospitalization; Required Intervention;
Patient Age38 YR
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