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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
Catalog Number 74120152
Device Problems Patient-Device Incompatibility (2682); Insufficient Information (3190)
Patient Problems Hair Loss (1877); Inflammation (1932); Pain (1994); Swelling (2091); Visual Disturbances (2140); Toxicity (2333); Injury (2348); Osteolysis (2377); Weight Changes (2607); Limited Mobility Of The Implanted Joint (2671)
Event Date 08/14/2017
Event Type  Injury  
Event Description
It was reported that left hip revision surgery was performed due to physical injuries, pain, significantly elevated metal levels, metallosis, pseudotumor, swelling, inflammation, lack of mobility, bone loss, hair loss, skin problems, weight loss, and vision change.
 
Manufacturer Narrative
It was reported that left hip revision surgery was performed due to physical injuries, pain, significantly elevated metal levels, metallosis, pseudotumor, swelling, inflammation, lack of mobility, bone loss, hair loss, skin problems, weight loss, and vision change.During the revision the bhr head and bhr cup were removed.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 devices reportedly involved in this incident.All the released devices involved met manufacturing specifications at the time of production.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 later revision.According to the provided revision report, the patient was doing well until approximately half a year before the revision, when after a fall the patient started having groin pain.The patient had elevated blood metal ions, but values were not reported.During the revision metallosis within the capsule and at the backside of the cup.The femoral component was loose, the acetabular cup not completely.The acetabulum was diagnosed had fractured with likely union.Some osteolysis was also noted at the acetabulum.Based on the provided surgical report it is remains unclear what caused the femoral component loosening and whether there is a relation to the reported fall.Furthermore, it remains unclear whether the remaining issues and intra-operative findings originate from the fall/fracture or from the loose cup or other reasons.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.If the products or additional information become available in the future, this case will be reopened.No preventative or corrective action has been initiated as a result of this investigation.
 
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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 Key7564673
MDR Text Key109892666
Report Number3005975929-2018-00189
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
Report Date 11/29/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received06/04/2018
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator Health Professional
Device Expiration Date10/31/2012
Device Catalogue Number74120152
Device Lot Number080223
Was Device Available for Evaluation? No
Date Manufacturer Received05/23/2018
Patient Sequence Number1
Treatment
(B)(4); FEMORAL HEAD, PART AND LOT # UNKNOWN; FEMORAL HEAD, PART AND LOT # UNKNOWN
Patient Outcome(s) Hospitalization; Required Intervention;
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