MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH ALUMINA V40-FEMORAL HEAD 32MM, +4MM NK; PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, CEMENTED

Catalog Number	6565-0-232
Medical Device Problem Codes	Material Deformation (2976); Noise, Audible (3273)
Health Effect - Clinical Code	Injury (2348)
Date of Event	12/26/2007
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
An event regarding wear and noise involving a ceramic head was reported.The event was confirmed through medical review.Method & results: device evaluation and results: could not be performed as the subject device was not returned.Medical records received and evaluation: a review of the primary, revision operative reports, office notes and x-rays by the consulting clinician indicated that "no examination of the explanted components, no x-rays of the dislocated right total hip, and no follow-up subsequent to the (b)(6) 2009 visit are available.The dislocations occurred after revision of the acetabular component to a competitor product.The squeaking of the right ceramic-ceramic total hip was first reported in (b)(6) 2007 and described on an office visit on (b)(6) 2007.At revision, as well as noted by me on x-ray, the right acetabular component was described as vertical and excessively anteverted.This could have resulted in repeated subluxation of the alumina head explaining the stripe wear noted at revision.Increased squeaking has been noted in ceramic-ceramic hip arthroplasties in which the acetabular component is more vertical than nominal.This may be relevant in this case." device history review indicated the devices accepted into final stock from the reported lot were free from discrepancies.Complaint history review: there has been no other event for the lot referenced.Conclusion: the reported event was confirmed.However, a root cause could not be determined on the basis of the review of the medical records indicating "a review of the primary, revision operative reports, office notes and x-rays by the consulting clinician indicated that "no examination of the explanted components, no x-rays of the dislocated right total hip, and no follow-up subsequent to the (b)(6) 2009 visit are available.The dislocations occurred after revision of the acetabular component to a competitor product.The squeaking of the right ceramic-ceramic total hip was first reported in (b)(6) 2007 and described on an office visit on (b)(6) 2007.At revision, as well as noted by me on x-ray, the right acetabular component was described as vertical and excessively anteverted.This could have resulted in repeated subluxation of the alumina head explaining the stripe wear noted at revision.Increased squeaking has been noted in ceramic-ceramic hip arthroplasties in which the acetabular component is more vertical than nominal.This may be relevant in this case." stryker orthopaedics conducted an investigation to evaluate reports of audible noise during motion involving trident ceramic bearing systems.An analysis of the overall complaint data, and additional information concerning this evaluation is documented in a capa.Stryker orthopaedics determined that the root cause of squeaking is associated with repetitive edge loading of the femoral bearing against the edge of the ceramic insert.Edge loading, the mechanism by which a wear scar (stripe wear) is generated on the ceramic bearing surfaces, is primarily associated with impingement, joint laxity, and implant orientation.Based on laboratory testing the combinations required to produce an audible noise are multi-factorial and include the right combination of load, contact stress, load transition and lubrication conditions with the presence of stripe wear being a critical factor.If devices and / or additional information become available, this investigation will be reopened.Not returned.
Event or Problem Description
It was reported that the patient, "had a trident hemispherical right hip replacement surgery on (b)(6) 2006." it is further reported that, "on (b)(6) 2007, the patient underwent revision of the right hip." per review of medical records [.] "on (b)(6) 2007 it was noted she "began to notice squeaking on right hip since (b)(6) 2007, increasing, and now grinding-like and rusty door closing".[.]it was noted that her hip "readily squeaks as she walks through the office" and that the "squeak is unacceptable to her''."on (b)(6) 2007 a revision of the right total hip arthroplasty was performed for which an operative report describes regional anesthesia and a posterolateral approach for a diagnosis of aseptic failure due to bearing surface wear and implant failure.During surgery the "ceramic head had a large focus of stripe wear".The acetabular component was "noted to be moderately vertical and severely anteverted at around 60°".Three screws were removed after the liner and the cup was removed with the implex acetabular osteotome device with minimal evidence of bone ingrowth.".

• Brand Name: ALUMINA V40-FEMORAL HEAD 32MM, +4MM NK
• Common Device Name: PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, CEMENTED
• Manufacturer (Section D): STRYKER ORTHOPAEDICS-MAHWAH; 325 corporate drive; mahwah NJ 07430
• MDR Report Key: 8267696
• Report Number: 0002249697-2019-00255
• Device Sequence Number: 2198098
• Product Code: JDI
• UDI-Device Identifier: 04546540390509
• UDI-Public: 04546540390509
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K173499
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2006
• Device Explanted Year: 2007
• Reporter Type: Manufacturer
• Report Source: consumer,other
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 01/22/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Expiration Date: 10/31/2009
• Device Catalogue Number: 6565-0-232
• Device Lot Number: 11016702
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/26/2018
• Initial Report FDA Received Date: 01/22/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention
• Patient Age: 59 YR
• Patient Weight: 84