MAUDE Adverse Event Report: SMITH & NEPHEW ORTHOPAEDICS LTD ACETLR CUP HAP 50MM W/ IMPTR; PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/METAL, RESURFACING

Catalog Number 74120150

Device Problem Insufficient Information (3190)

Patient Problems Pain (1994); Toxicity (2333); No Code Available (3191)

Event Date 03/31/2016

Event Type  Injury  

Event Description

It was reported that right hip revision surgery was performed due to pain, elevated chromium and cobalt levels and metallosis.

Manufacturer Narrative

It was reported that right hip revision surgery was performed due to pain, elevated chromium and cobalt levels and metallosis.At the time of revision, both the bhr head & cup were revised.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 for bhr cup confirmed all released devices met specifications applicable at the time of production.The production records for the bhr head were also reviewed, and the original order of (b)(4) devices met specifications applicable at the time of production.23 of these cups were subject to repackaging following us fda approval of bhr in 2006; unfortunately, the full corresponding repackaging production documents could not be located.However, the supplier's certificate of conformity has been located and evidences all (b)(4) were released and meeting specifications.The missing repackaging record has been addressed through a non-conformance report.Repackaging would not have altered the physical dimensions of the product.Review of available medical documents was conducted.Review of the provided implantation report did not reveal any inconsistencies related to the surgical technique that could explain the later revision.The provided mri report 2.5 months before revision, indicated that there was a subchondral cyst at the acetabulum and large trochanteric bursa.The provided report dated 3 weeks before the revision indicates that whole blood chromium was elevated with respect to reference (9.5 ug/l, ref.<3), as was cobalt (22.1 ug/l, ref.<3).According to the provided revision report, there was osteolysis, significant metallosis and fluid inside the capsule.The complete psoas muscle was completely detached form the lesser trochanter and the posterior abductor mechanism was partial detachment.The provided information may be consistent with an adverse reaction to metal debris.Whether the detachment of the hip muscles was a result of it or has contributed to the reported finding (e.G.Via instability of the hip replacement) was not further specified.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 further preventative or corrective action has been initiated as a result of this investigation.

• Brand Name: ACETLR CUP HAP 50MM W/ IMPTR
• 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 Key: 7024081
• MDR Text Key: 91777889
• Report Number: 3005975929-2017-00392
• Device Sequence Number: 1
• Product Code: NXT
• Combination Product (y/n): N
• PMA/PMN Number: P040033
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer,other
• Type of Report: Initial,Followup
• Report Date: 09/19/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/13/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 01/31/2011
• Device Catalogue Number: 74120150
• Device Lot Number: 089042
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 11/07/2017
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: 74121142/RESURFACINGFEMORALHEAD42MM/59556/5955; FEMORAL HEAD, PART AND LOT # UNKNOWN; FEMORAL HEAD, PART AND LOT # UNKNOWN
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 56 YR