MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH 32MM STD V40 TAPER VIT HEAD; PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, CEMENTED

Model Number	6260-5-132
Medical Device Problem Code	Degraded (1153)
Health Effect - Clinical Codes	Bacterial Infection (1735); Pain (1994)
Date of Event	03/02/2022
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Reported event: an event regarding infection and fretting involving a metal head 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 was not returned.Clinician review: a review of the provided medical information by a clinical consultant indicated: this inquiry reports and infection of a right total hip replacement 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 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 and 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.The following devices were also listed in this report: trident 10° crossfire insert 32 mm id; cat#621-10-32g; lot#82727701, trident hemispherical solid bk 60mm; cat#500-01-60g; lot#15856801.It cannot be determined which, if any of these devices may have caused or contributed to the patient's experience.H3 other text : device not returned to the manufacturer.
Event or Problem Description
Patient's daughter stated her father had a right tha and 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 and 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.They performed an i&d but the patient was not revised due to his age and bone loss.Patient was told that his implants are part of a recall while at the hospital.Patient would like to confirm if his implants are part of a recall as he was never notified of the recall.The operation also revealed mild trunnionosis.
Event or Problem Description
Patient's daughter stated her father had a right tha and 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 and 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.They performed an i&d but the patient was not revised due to his age and bone loss.Patient was told that his implants are part of a recall while at the hospital.Patient would like to confirm if his implants are part of a recall as he was never notified of the recall.The operation also revealed mild trunnionosis.
Additional Manufacturer Narrative
Reported event: an event regarding infection and fretting involving a metal head 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 was not returned.-clinician review: 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.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 by 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: 32MM STD V40 TAPER VIT HEAD
• Common Device Name: PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, CEMENTED
• Manufacturer (Section D): STRYKER ORTHOPAEDICS-MAHWAH; 325 corporate drive; mahwah NJ 07430
• Manufacturer (Section G): STRYKER ORTHOPAEDICS-CORK; ida industrial estate; carrigtwohill NA ; EI NA
• Manufacturer Contact: arokiya raj ; 325 corporate drive; mahwah, NJ 07430 ; 2018315000
• MDR Report Key: 15046010
• Report Number: 0002249697-2022-01025
• Device Sequence Number: 14853361
• Product Code: JDI
• UDI-Device Identifier: 07613327012873
• UDI-Public: 07613327012873
• Combination Product (Y/N): N
• Initial Reporter State: OH
• Initial Reporter Country: US
• PMA/510(K) Number: K121308
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2006
• Device Explanted Year: 2022
• Reporter Type: Manufacturer
• Report Source: Consumer
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 07/21/2022

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
• Operator of Device: Health Professional
• Device Expiration Date: 07/30/2011
• Device Model Number: 6260-5-132
• Device Catalogue Number: 6260-5-132
• Device Lot Number: 19430704
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 06/22/2022
• Supplement Date Received by Manufacturer: 06/24/2022
• Initial Report FDA Received Date: 07/18/2022
• Supplement Report FDA Received Date: 07/21/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 07/07/2006
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention
• Patient Age: 73 YR
• Patient Sex: Male
• Patient Weight: 68 KG