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

Model Number 6260-9-132

Device Problems Degraded (1153); Material Erosion (1214)

Patient Problems Foreign Body Reaction (1868); Metal Related Pathology (4530)

Event Date 06/13/2022

Event Type  Injury  

Event Description

It was reported that the patient's right hip was revised due to metallosis.A femoral head was revised to a ceramic head and sleeve.Rep confirmed that pictures can be provided.Otherwise, no further information will be released by the hospital or surgeon.

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.

Event Description

It was reported that the patient's right hip was revised due to metallosis.A femoral head was revised to a ceramic head and sleeve.Rep confirmed that pictures can be provided.Otherwise, no further information will be released by the hospital or surgeon.

Manufacturer Narrative

Reported event: an event regarding wear/metallosis involving a metal head was reported.The event was not confirmed.Method & results: -product evaluation and results: the reported device was not returned however photographs were provided for review.Visual inspection of the provided photographs indicated that the device was recently explanted as it is covered in blood.It appears that there is some dark discoloration or dark material on the inner taper of the head, but nothing can be concluded from the provided images due to the quality of the photo and the bodily fluids present on the device.-clinician review: a review of the provided medical information by a clinical consultant indicated: "this patient underwent a right total hip arthroplasty and approximately six years later required revision surgery for metallosis.I can confirm that this event occurred since i was able to see the intraoperative photos of the explanted femoral head and the femoral trunnion.The root cause of this event cannot be determined with certainty.The causes of metallosis following total hip arthroplasty are multifactorial including surgical technique, preparation of the trunnion and implanted femoral head, patient factors such as bmi and activity level (this patient was obese), and implant factors." -product history review: could not be performed as the device lot details were not provided.-complaint history review: could not be performed as the device lot details were not provided.Conclusions: it was reported that the patient was revised due to metallosis.The reported device was not returned however photographs were provided for review.Visual inspection of the provided photographs indicated that the device was recently explanted as it is covered in blood.It appears that there is some dark discoloration or dark material on the inner taper of the head, but nothing can be concluded from the provided images due to the quality of the photo and the bodily fluids present on the device.A review of the provided medical records by a clinician indicated the following: "the root cause of this event cannot be determined with certainty.The causes of metallosis following total hip arthroplasty are multifactorial including surgical technique, preparation of the trunnion and implanted femoral head, patient factors such as bmi and activity level (this patient was obese), and implant factors." the exact cause of the event could not be determined because insufficient information was provided.Further information such as return of the device, pathology reports, and the revision operative report as well as patient history and follow-up notes are needed to complete the investigation for determining root cause.No further investigation for this event is possible at this time.If devices and/or additional information become available to indicate further evaluation is warranted, this record will be reopened.

• Brand Name: 32MM STD LFIT V40 HEAD
• Type of Device: PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, CEMENTED
• Manufacturer (Section D): STRYKER ORTHOPAEDICS-MAHWAH; 325 corporate drive; mahwah NJ 07430
• Manufacturer (Section G): STRYKER ORTHOPAEDICS-MAHWAH; 325 corporate drive; mahwah NJ 07430
• Manufacturer Contact: anna ryan ; raheen business park; limerick NA ; EI NA ; 61498200
• MDR Report Key: 14920886
• MDR Text Key: 295310429
• Report Number: 0002249697-2022-00967
• Device Sequence Number: 1
• Product Code: JDI
• UDI-Device Identifier: 07613327013047
• UDI-Public: 07613327013047
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K173499
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 10/19/2022

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 Model Number: 6260-9-132
• Device Catalogue Number: 6260-9-132
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 06/13/2022
• Initial Date FDA Received: 07/05/2022
• Supplement Dates Manufacturer Received: 09/27/2022
• Supplement Dates FDA Received: 10/19/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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: 65 YR
• Patient Sex: Female
• Patient Weight: 83 KG