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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: SMITH & NEPHEW ORTHOPAEDICS LTD BHR ACETABULAR CUP 58MM; PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/METAL, RESURFACING
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SMITH & NEPHEW ORTHOPAEDICS LTD BHR ACETABULAR CUP 58MM; PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/METAL, RESURFACING Back to Search Results
Model Number 74122158
Device Problems Device Dislodged or Dislocated (2923); Patient Device Interaction Problem (4001)
Patient Problems Joint Dislocation (2374); No Code Available (3191)
Event Date 05/29/2018
Event Type  Injury  
Event Description
It was reported that a right hip revision surgery was performed due to dislocation.
 
Manufacturer Narrative
Smith & nephew is submitting this report pursuant to the provisions of 21 cfr, part 803.This report may be based upon information which smith & nephew, has not been able to investigate or verify prior to the required reporting date.This report does not reflect a conclusion by fda, smith & nephew, or its employees, that the report constitutes an admission that the device, smith & nephew, or its employees caused or contributed to the potential event described in this report.- attachment: [198338 summary.Pdf].
 
Manufacturer Narrative
Smith & nephew is submitting this report pursuant to the provisions of 21 cfr, part 803.This report may be based upon information which smith & nephew, has not been able to investigate or verify prior to the required reporting date.This report does not reflect a conclusion by fda, smith & nephew, or its employees, that the report constitutes an admission that the device, smith & nephew, or its employees caused or contributed to the potential event described in this report.
 
Manufacturer Narrative
A modular head (74432052, 09ew23222 serial no (b)(6)), bhr cup (74122158, 10aw25636 serial no (b)(6)) & bmhr stem (74431313, 08hw18524) were received following a right hip revision surgery due to dislocation, all of which were used in treatment.A review of the complaint history for the cup, head & stem was performed using batch numbers in search of similar recurring reports for the products during their lifetimes.No other complaints have been identified for the head.Similar complaints have been identified for the cup & stem and this will continue to be monitored.In the absence of the actual devices, the production records were reviewed for the devices reportedly involved in this incident.Device history record review confirmed that all released parts met specifications applicable at the time of production.Review of the product ifu found adequate warnings and precautions in relation to the alleged failure modes.A risk management review was performed.No additional risks were identified as result of the reported event.No further actions are required at this time.Visual inspection was carried out on the returned devices.For the bmhr modular head a wear patch was observed on the bearing surface along with patches of surface discolouration.Damage was also noted on the rim of the head.Discolouration and surface texture changes were noted on the head taper.For the bhr cup a patch of wear was observed on the bearing surface.Damage and scratches were noted on the bmhr stem, further dents were noted at multiple sites.Discolouration and surface texture change was noted on the stem taper.Wear analysis of the head and cup was performed and a maximum linear wear of 36.9¿m for the head could be measured.Wear analysis of the cup was performed and a maximum linear wear of 27.4¿m for a combined head & cup maximum wear of 64.3¿m.Based on historic wear data, after 8.10 years in vivo, the combined maximum linear wear for this device is higher than the expected wear for a non-edge loaded smith and nephew large diameter metal-on-metal device.The position of wear on the acetabular cup shows that edge loading has occurred.Depth of material loss on a bmhr head and stem tapers could not be measured using the vertical straightness technique due to lack of a non-contact reference on the taper.The medical documents have been reviewed.It should be noted the surgical technique for bmhr indicates a size 4 stem should be used with the acetabular cup sz 52/58 and 52mm bmhr modular head.The implantation of the size 3 stem cannot be ruled out as a contributing factor to the patient¿s pain and the intraoperative findings effusion, trunnion wear and corrosion.The patients¿ comorbidities cannot be ruled out as contributing factors to his pain and clinical status.The reported elevated chromium and cobalt levels, hip pain and intraoperative findings of corrosion and trunionosis may be consistent with findings associated with metal debris.However, the root cause cannot be confirmed though the report of edge loading cannot be ruled out based on the information provided, and it cannot be concluded that the reported reactions were associated with a mal-performance of the implant.The patient impact beyond the pain, revision, and expected transient post-op convalescence period cannot be determined.Based on the available information the root cause of improper components has been chosen due to the mismatch of sizes used.If additional information becomes available in the future, this case will be reopened.No preventative or corrective action has been initiated as a result of this investigation.The devices will be retained at aurora uk and are available if requested.
 
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Brand Name
BHR ACETABULAR CUP 58MM
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 Key7608950
MDR Text Key111299737
Report Number3005975929-2018-00203
Device Sequence Number1
Product Code NXT
UDI-Device Identifier03596010552310
UDI-Public03596010552310
Combination Product (y/n)N
PMA/PMN Number
P040033
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Type of Report Initial,Followup,Followup,Followup
Report Date 05/20/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received06/18/2018
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator Health Professional
Device Expiration Date01/31/2015
Device Model Number74122158
Device Catalogue Number74122158
Device Lot Number10AW25636
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer06/14/2018
Date Manufacturer Received05/19/2020
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Treatment
74431313/08HW18524/BMHR HAP STEM VST SZ 3.; 74432052/09EW23222/BMHR MODULAR HEAD 52MM.; 74431313/08HW18524/BMHR HAP STEM VST SZ 3; 74432052/09EW23222/BMHR MODULAR HEAD 52MM
Patient Outcome(s) Hospitalization; Required Intervention;
Patient Age47 YR
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