MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH ACCOLADE PLUS TMZF HIP STEM #4; PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED

Model Number 6021-0435

Device Problems Degraded (1153); Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Bacterial Infection (1735); Unspecified Infection (1930); Pain (1994); Discomfort (2330)

Event Date 03/02/2022

Event Type  Injury  

Manufacturer Narrative

It was noted that the device is not available for evaluation.Should additional information become available, it will be provided in a supplemental report upon completion of the investigation.Device not returned to the manufacturer.

Event Description

Patient's daughter stated her father had a right tha done on (b)(6) 2006.On (b)(6) patient felt a discomfort on his hip.Patient felt extreme pain when he tried walking and when trying to extend his leg.Patient was brought to the er on (b)(6).Patient was given mri, x-ray images, ct scan which confirmed an infection.While at the er, the surgeon drained some infection to alleviate the pain the patient was experiencing.On (b)(6) they performed an i&d but the patient was not revised due to his age and bone loss.

Event Description

Patient's daughter stated her father had a right tha done on (b)(6) 2006.On (b)(6) patient felt a discomfort on his hip.Patient felt extreme pain when he tried walking and when trying to extend his leg.Patient was brought to the er on (b)(6).Patient was given mri, x-ray images, ct scan which confirmed an infection.While at the er, the surgeon drained some infection to alleviate the pain the patient was experiencing.On (b)(6) they performed an i&d but the patient was not revised due to his age and bone loss.Update: as per medical review addendum dated 18 april 2022: "this inquiry reports and infection of a right total hip replacement approximately 15 years after implantation and an operation to treat the infection.The operation revealed infection and ¿mild trunnionosis¿".

Manufacturer Narrative

Reported event: an event regarding infection and fretting involving an accolade stem was reported.The event was confirmed through clinician review of the provided medical records.Method & results: -product evaluation and results: material analysis, visual, functional and dimensional inspections could not be performed as the device remains implanted.-clinician review: a review of the provided medical information by a clinical consultant indicated: this inquiry reports an infection of a right total hip replacement approximately 15 years after implantation and an operation to treat the infection.The operation revealed infection and ¿mild trunnionosis¿.I can confirm that this event took place since i was able to see a pathology report showing inflammation and explanted components including an acetabular liner and a femoral head and positive cultures from aspiration of the hip.I was also able to now see the original and subsequent operation reports.Regarding the possible root cause of this event, i cannot determine it with certainty.Causes of late infection of a total hip replacement are multifactorial.Most likely the cause would be secondary seeding of the hip from a remote source.Causes of trunnionosis are multifactorial including surgical factors, patient factors and implant factors.Regarding the possibility of the implant being part of a recall, the original stryker stickers are available and stryker would have to determine if this particular lot was part of a recall.-product history review: review of the device history records indicate 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 or sterile lot referenced.Conclusion: a review of the provided medical information by a clinical consultant indicated: this inquiry reports and infection of a right total hip replacement approximately 15 years after implantation and an operation to treat the infection.The operation revealed infection and ¿mild trunnionosis¿.I can confirm that this event took place since i was able to see a pathology report showing inflammation and explanted components including an acetabular liner and a femoral head and positive cultures from aspiration of the hip.I was also able to now see the original and subsequent operation reports.Regarding the possible root cause of this event, i cannot determine it with certainty.Causes of late infection of a total hip replacement are multifactorial.Most likely the cause would be secondary seeding of the hip from a remote source.Causes of trunnionosis are multifactorial including surgical factors, patient factors and implant factors.It is also noted that the patient would like to confirm if his implants are part of a recall as he was never notified of the recall.Based on the catalog numbers and lot codes provided the device reported in this investigation is not subject to or part of a recall.A microbiological assessment was completed, principal microbiologist, stryker ireland who concluded: due to the nature of the organism isolated ¿ susceptible to various modes of sterilisation - and specifically the sterilisation methodologies and modalities employed by stryker, it is not probable that streptococcus salivarius could have originated from the sterile implants.No further investigation for this event is possible at this time.If additional information becomes available to indicate further evaluation is warranted, this record will be reopened.

• Brand Name: ACCOLADE PLUS TMZF HIP STEM #4
• Type of Device: PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED
• Manufacturer (Section D): STRYKER ORTHOPAEDICS-MAHWAH; 325 corporate drive; mahwah NJ 07430
• Manufacturer (Section G): STRYKER ORTHOPAEDICS-CORK; ida industrial estate; carrigtwohill NJ NA ; EI NA
• Manufacturer Contact: marisol santiago ; 325 corporate drive; mahwah, NJ 07430 ; 2018315000
• MDR Report Key: 14050245
• MDR Text Key: 288851056
• Report Number: 0002249697-2022-00485
• Device Sequence Number: 1
• Product Code: LPH
• UDI-Device Identifier: 04546540510693
• UDI-Public: 04546540510693
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K121308
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Consumer
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 07/20/2022

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
• Device Operator: Health Professional
• Device Expiration Date: 07/31/2011
• Device Model Number: 6021-0435
• Device Catalogue Number: 6021-0435
• Device Lot Number: 18895101
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 03/16/2022
• Initial Date FDA Received: 04/08/2022
• Supplement Dates Manufacturer Received: 06/24/2022
• Supplement Dates FDA Received: 07/20/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 07/13/2006
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention; Hospitalization
• Patient Age: 73 YR
• Patient Sex: Male
• Patient Weight: 68 KG