MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH ALUMINA V40-FEMORAL HEAD 36MM, -5MM NK; PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, CEMENTED

Model Number	6565-0-036
Medical Device Problem Codes	Insufficient Device Problem Information (3190); Noise, Audible (3273)
Health Effect - Clinical Codes	Pain (1994); Metal Related Pathology (4530)
Date of Event	09/09/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Review of the device history records indicate that devices were manufactured and accepted into final stock with no reported discrepancies.There have been no other events for the lot referenced.If additional information is received, it will be provided in a supplemental report upon completion of the investigation.
Event or Problem Description
Revision surgery on stryker implants.Replaced with stryker stem and femoral head and depuy cup and insert (b)(6) 2020.Patient complaint of pain and squeek / clunkiness.Signs of trunnionosis and impingement noted by surgeon.Stripe wear on ceramic head.Liner rim damaged by wear from stem.Revision on previous primary surgery.
Event or Problem Description
Revision surgery on stryker implants.Replaced with stryker stem and femoral head and depuy cup and insert on (b)(6) 2020.Patient complaint of pain and squeek / clunkiness.Signs of trunionosis and impingement noted by surgeon.Stripe wear on ceramic head.Liner rim damaged by wear from stem.Revision on previous primary surgery.
Additional Manufacturer Narrative
An event regarding audible noise and wear and involving alumina v40-femoral head 36mm, -5mm nk was reported.The event was not confirmed method & results: device evaluation and results: visual inspection: the reported device was not returned however photographs were provided for review.The photos provided show a significant amount of blood on the the explanted head with damage observed on the surface.This damage is likely due to explanation of the device.There is nothing else remarkable of note.Material analysis, functional and dimensional inspections could not be performed as the device was not returned.Clinician review: a review of the provided medical records by a clinical consultant stated the following comment: the event can be confirmed.Revision surgery was performed impingement evident form deformation of shell stripe wear on head op note outlined blackened tissue, indentation of femoral neck, indentation of acetabular rim, stable components.Clunk noted on exam squeaking not confirmed root cause was likely cup-stem positioning with resultant implant impingement.Inspection of implants should confirm the finding in addition to the photos.No obvious implant issues.Squeak cannot be confirmed, preoperative notes/clinic notes may confirm squeak.Squeak would be associated with reported incidence of alumina-alumina bearing.Device history review: all devices were manufactured and accepted into final stock with no relevant reported discrepancies.Complaint history review: there have been no other similar events for the lot referenced.Conclusion: it was reported that patient was revised due to pain and squeak / clunkiness.Signs of trunnionosis and impingement noted by surgeon.Stripe wear on ceramic head.Liner rim damaged by wear from stem.The event was not confirmed.A review of the provided medical records by a clinical consultant stated the following comment: the event can be confirmed.Revision surgery was performed impingement evident form deformation of shell stripe wear on head op note outlined blackened tissue, indentation of femoral neck, indentation of acetabular rim, stable components.Clunk noted on exam squeaking not confirmed.Root cause was likely cup-stem positioning with resultant implant impingement.Inspection of implants should confirm the finding in addition to the photos.No obvious implant issues.Squeak cannot be confirmed, preoperative notes/clinic notes may confirm squeak.Squeak would be associated with reported incidence of alumina-alumina bearing.The exact cause of the event could not be determined because insufficient information was provided.Additional information including progress notes and return of the device are needed to fully investigate the event.If further information becomes available or the product is returned, this investigation will be re-opened.Product surveillance will continue to monitor for trends.Corrective action/preventive action: per corrective action/preventive action policy and procedures 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.In the 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-factoral and include the right combination of load, contact stress, load transition and lubrication conditions with the presence of stripe wear being a critical factor.

• Brand Name: ALUMINA V40-FEMORAL HEAD 36MM, -5MM 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: 10631086
• Report Number: 0002249697-2020-02047
• Device Sequence Number: 19745103
• Product Code: JDI
• UDI-Device Identifier: 04546540402141
• UDI-Public: 04546540402141
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• PMA/510(K) Number: K173499
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2010
• Device Explanted Year: 2020
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 12/04/2020

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: 07/31/2013
• Device Model Number: 6565-0-036
• Device Catalogue Number: 6565-0-036
• Device Lot Number: 27535203
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 09/09/2020
• Supplement Date Received by Manufacturer: 11/09/2020
• Initial Report FDA Received Date: 10/05/2020
• Supplement Report FDA Received Date: 12/05/2020
• 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: Required Intervention
• Patient Age: 74 YR
• Patient Weight: 117