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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: SMITH & NEPHEW ORTHOPAEDICS LTD HEMI HEAD 46MM; PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/METAL, RESURFACING
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SMITH & NEPHEW ORTHOPAEDICS LTD HEMI HEAD 46MM; PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/METAL, RESURFACING Back to Search Results
Catalog Number 74122546
Device Problems Material Disintegration (1177); Insufficient Information (3190)
Patient Problems Failure of Implant (1924); Injury (2348); No Code Available (3191)
Event Date 06/19/2018
Event Type  Injury  
Event Description
It was reported that right hip revision surgery was scheduled to be performed due to metallosis.Previous bhr to thr revision captured under previous mdr.
 
Manufacturer Narrative
It was reported that right hip revision surgery was performed due to metallosis.During the revision the hemi head and sleeve were removed.The cup remained implanted for use with the bhr dual mobility liner.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.During the revision, normal-appearing synovial fluid was joint sent for cell count and culture; however, no laboratory results were provided.It was noted there was obvious metallosis and debris within the joint.It was also noted there was not a significant amount of metal staining; however, there was significant degenerative changes to the surrounding soft tissue with debris.Minimal trunnionosis of the femoral stem was noted.The intraoperative findings of metallosis and trunnionosis are consistent with an adverse reaction to metal debris; however, without the supporting lab/pathology results, imaging, and/or the analysis of the explanted components, the source cannot be confirmed, and it cannot be concluded that the reported metallosis was associated with a mal-performance of the implant.However, the reported trunnionosis and anterior impingement could not be ruled out as a contributing factor to the reported events.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
It was reported that right hip revision surgery was performed.During the revision, the hemi head and modular sleeve were removed.The bhr cup and anthology stem 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.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.Elevated ion levels, debris within the joint, pain, degenerative changes to soft tissue, debridement of the trunnion and osteolytic lesions are consistent with findings of metal debris.Without the supporting histopathology findings, images or the explant for analysis it cannot be concluded that the clinical reactions are associated with a mal-performance of the implant.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
HEMI HEAD 46MM
Type of Device
PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/METAL, RESURFACING
Manufacturer (Section D)
SMITH & NEPHEW ORTHOPAEDICS LTD
aurora house
spa park
leamington spa, CV313 HL
UK  CV313HL
MDR Report Key7673953
MDR Text Key113546157
Report Number3005975929-2018-00253
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 other
Type of Report Initial,Followup,Followup
Report Date 11/03/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received07/10/2018
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator Health Professional
Device Expiration Date10/31/2011
Device Catalogue Number74122546
Device Lot Number10032
Date Manufacturer Received06/19/2018
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Treatment
CUP HAP 54MM 74120154 LOT 59501; HEMI HEAD/UNKNOWN PART NUMBER/UNKNOWN LOT NUMBER; MODULAR SLEEVE 74222200 LOT 10063; MODULAR SLEEVE/UNKNOWN PART NUMBER/UNKNOWN LOT NUM; SYN POR PLUS HA SO STEM/UNKNOWN PART NUMBER/LOT NO; SYNERGY STEM 71357008 LOT 05MM03456A; HEMI HEAD/UNKNOWN PART NUMBER/UNKNOWN LOT NUMBER; MODULAR SLEEVE/UNKNOWN PART NUMBER/UNKNOWN LOT NUM; SYN POR PLUS HA SO STEM/UNKNOWN PART NUMBER/LOT NO
Patient Outcome(s) Hospitalization; Required Intervention;
Patient Age54 YR
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