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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: SMITH & NEPHEW ORTHOPAEDICS LTD HEMI HEAD 42MM; PROSTHESIS, HIP, HEMI-, FEMORAL, METAL
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SMITH & NEPHEW ORTHOPAEDICS LTD HEMI HEAD 42MM; PROSTHESIS, HIP, HEMI-, FEMORAL, METAL Back to Search Results
Catalog Number 74122542
Device Problem Biocompatibility (2886)
Patient Problems Pain (1994); Synovitis (2094); Metal Related Pathology (4530)
Event Date 11/12/2019
Event Type  Injury  
Event Description
*us legal mdl* it was reported that, after a bhr tha construct had been implanted on (b)(6) 2008, the plaintiff experienced metal-on-metal pain reaction with synovitis, and elevated ion levels.A revision surgery was performed on (b)(6) 2019 to treat this adverse event.During the revision surgery, metallosis was found on the femoral head and trunnion.The femoral head was explanted.The patient outcome is unknown.
 
Manufacturer Narrative
Internal reference number: (b)(4).
 
Event Description
*us legal mdl* it was reported that, after a bhr tha construct had been implanted on (b)(6) 2008, the plaintiff experienced metal-on-metal pain reaction with synovitis, and elevated ion levels.A revision surgery was performed on (b)(6) 2019 to treat this adverse event.During the revision surgery, metallosis was found on the femoral head and trunnion.The femoral head was explanted.The patient outcome is unknown.After revision surgery plaintiff develop foot drop (cover under case (b)(4)).The left hip, however, did not presented any other complications.
 
Manufacturer Narrative
H3, h6: it was reported that left hip revision has been performed.As of today, the implanted devices all of which were used in the treatment, and additional information has been requested for this complaint but has not become available.Without definitive lot numbers, a complete complaint history review cannot be performed for the devices involved.As no device batch numbers were provided for investigation, a manufacturing record review and device labelling / ifu review could not be performed.All of the devices would have met manufacturing specifications.If more information is received, this investigation will be reopened.A risk management review was performed.No additional risks were identified as result of the reported event and no further actions are required at this time.The available medical documents have been reviewed.Per the surgical technique, the acetabular component is to be impacted with 15-20° of anteversion.However, the implantation operative report indicated the hip was placed at about 35°of anteversion.It is unknown if the increased anteversion of the acetabular component led to accelerated wear and the reported ¿metal-on-metal pain reaction with synovitis, elevated ion levels¿, and intraoperative findings of black char type material on the trunnion.Without the supporting lab/pathology results, imaging, and/or the analysis of the explanted components, the root cause of the events cannot be confirmed.It cannot be concluded that the reported clinical reactions were associated with a mal-performance of the implant or implant failure.The patient impact beyond the pain, revision, and expected transient post-op convalescence period cannot be determined.Without return of the actual devices or further information we cannot further investigate or confirm the details supplied in this complaint.The investigation remains inconclusive and a definitive root cause cannot be determined.Additionally, specific factors known to contribute to the alleged fault cannot be provided due to the insufficient information.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
G3, h2, h3, and h6: it was reported that a left hip revision surgery was performed due to elevated metal ion levels and a metal-on-metal pain reaction with synovitis.The hemi-head used in treatment was explanted but was not returned for evaluation.The other devices used in treatment remain implanted in the patient, hence cannot be returned for evaluation.Additional information has been requested for this complaint but has not become available.A review of the complaint history for the cup, hemi-head, modular sleeve was performed using batch numbers in search of similar recurring reports for the products during their lifetimes.No other similar complaints have been identified for the hemi-head.Similar complaints have been identified for the sleeve.However, as the device is no longer sold, no action is to be taken.A similar complaint has been identified for the cup, though this relates to the same patient and device.On account of the fact devices reportedly involved in this incident were not returned for evaluation, the relevant production records were reviewed.All released devices involved met manufacturing specifications upon release for distribution.Review of manufacturing records did not reveal any waivers, concessions, manufacturing, or material abnormalities that could have contributed to this issue.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.The available medical documents were reviewed.Per the surgical technique, the acetabular component is to be impacted with 15-20° of anteversion.However, the implantation operative report indicated the hip was placed at about 35°of anteversion.It is unknown if the increased anteversion of the acetabular component led to accelerated wear and the reported ¿metal-on-metal pain reaction with synovitis, elevated ion levels¿, and intraoperative findings of black char type material on the trunnion.Based on the information provided, the clinical root cause of the reported events cannot be confirmed.It cannot be concluded that the reported clinical reactions were associated with a malperformance of the implant or implant failure.The patient impact beyond the pain, revision, and expected transient post-op convalescence period cannot be determined.Without the return of the actual product involved or further product information, our investigation could not proceed and remains inconclusive, and a definitive root cause cannot be determined.Furthermore, based on the limited information provided, we are unable to determine specific factors known to contribute to the alleged fault.Should the device or additional information be received, the complaint will be reopened.Based on this investigation, the need for corrective and preventative actions is not indicated.A2: patient information available.D10: add concomitants g4: add 510k code.H6: update codes.
 
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Brand Name
HEMI HEAD 42MM
Type of Device
PROSTHESIS, HIP, HEMI-, FEMORAL, METAL
Manufacturer (Section D)
SMITH & NEPHEW ORTHOPAEDICS LTD
aurora house, spa park
leamington spa warwickshire CV31 3HL
UK  CV31 3HL
Manufacturer (Section G)
SMITH & NEPHEW ORTHOPAEDICS LTD
aurora house, spa park
leamington spa warwickshire CV31 3HL
UK   CV31 3HL
Manufacturer Contact
holly topping
7000 west william cannon drive
austin, TX 78735
5123913905
MDR Report Key12135376
MDR Text Key260479419
Report Number3005975929-2021-00350
Device Sequence Number1
Product Code KWL
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K062408
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Company Representative
Reporter Occupation Other
Type of Report Initial,Followup,Followup,Followup
Report Date 11/08/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received07/08/2021
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Catalogue Number74122542
Device Lot Number10537
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? No
Date Manufacturer Received11/05/2021
Was Device Evaluated by Manufacturer? No
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Patient Sequence Number1
Treatment
74120150 / ACETABULAR CUP BHR / 083248; 74222100 / MODULAR HEAD SLEEVE / LOT: 11440; 74435942 / STEM, HIP PLATFORM / LOT: 07EW12088; ACETLR CUP HAP 50MM W/ IMPTR/083248; MODULAR SLEEVE -4MM 12/14/ 11440; PLATFORM HO CMTLSS FEM SZ 2/07EW12088
Patient Outcome(s) Hospitalization; Required Intervention; Other;
Patient Age39 YR
Patient SexFemale
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