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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: SMITH & NEPHEW ORTHOPAEDICS LTD HEMI HEAD 54MM; PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/METAL, RESURFACING
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SMITH & NEPHEW ORTHOPAEDICS LTD HEMI HEAD 54MM; PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/METAL, RESURFACING Back to Search Results
Catalog Number 74122554
Device Problems Corroded (1131); Metal Shedding Debris (1804); Patient Device Interaction Problem (4001)
Patient Problems Pain (1994); Tissue Damage (2104); Joint Swelling (2356); Joint Disorder (2373); Test Result (2695)
Event Date 02/01/2018
Event Type  Injury  
Event Description
It was reported that left hip revision surgery was performed due to pain and other complications.Operative report noted pseudotumor, large-volume metallic debris fragments, significant amount of corrosion products, grey/maroon/black fluid in the hip joint capsule, and elevated metal ion levels in hip joint.
 
Manufacturer Narrative
It was reported that left hip revision surgery was performed due to pain and other complications.During the revision the hemi head and modular sleeve were removed.The femoral stem and bhr cup remained implanted.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.According to the provided revision report, there was a metal pseudotumor, large volume metallic debris, dark grey/maroon/black fluid in the joint capsule and corrosion was significant at the neck taper and the ball head.The final diagnosis was adverse reaction to metal debris (armd).No information on the mentioned blood metal ion concentrations was provided.No histopathological analysis was provided with further details about the intra-operative findings.No x-rays were available to assess the implant position and fixation during the time in-vivo.Review of the provided implantation report did not reveal any inconsistencies related to the surgical technique that could explain the later revision.As the device was not available for analysis, it remain unclear whether the reported findings correlate with corrosion or material loss at the taper junction or the articulation junctions and the reasons for the reported finding cannot be further investigated.It was noted that use of a competitor¿s (biomet) dual mobility liner, was implanted with the bhr cup at the time of revision.This activity was performed contrary to the instructions for use of for bhr implants which states under its important medical information, ¿do not mix components from other manufacturers.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.
 
Manufacturer Narrative
Smith + nephew is submitting this report pursuant to the provisions of 21cfr, 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.
 
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Brand Name
HEMI HEAD 54MM
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 Key7564582
MDR Text Key109895349
Report Number3005975929-2018-00187
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
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 Date04/30/2013
Device Catalogue Number74122554
Device Lot Number08JW18693
Was Device Available for Evaluation? No
Date Manufacturer Received05/23/2018
Patient Sequence Number1
Treatment
71309015/SYN POR PLUS HA SO STEM SZ 15/11HM17604; 74120160/ACETLR CUP HAP 60MM W/ IMPTR/087037; 74222200/MODULAR SLEEVEPLUS 0MM 12/14/10ET42417; FEMORAL STEM, PART AND LOT # UNKNOWN; HEMI HEAD, PART AND LOT # UNKNOWN; MODULAR SLEEVE, PART AND LOT # UNKNOWN; 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 Age37 YR
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