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

Model Number	6260-9-132
Medical Device Problem Codes	Degraded (1153); Material Erosion (1214)
Health Effect - Clinical Codes	Foreign Body Reaction (1868); Metal Related Pathology (4530)
Date of Event	06/13/2022
Type of Reportable Event	Serious Injury
Event or Problem 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.
Additional 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 or Problem 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.
Additional 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
• 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-MAHWAH; 325 corporate drive; mahwah NJ 07430
• Manufacturer Contact: anna ryan ; raheen business park; limerick NA ; EI NA ; 61498200
• MDR Report Key: 14920886
• Report Number: 0002249697-2022-00967
• Device Sequence Number: 6204030
• Product Code: JDI
• UDI-Device Identifier: 07613327013047
• UDI-Public: 07613327013047
• Combination Product (Y/N): N
• Initial Reporter State: NY
• Initial Reporter Country: US
• PMA/510(K) Number: K173499
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2016
• Device Explanted Year: 2022
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 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
• Operator of Device: 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
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 06/13/2022
• Supplement Date Received by Manufacturer: 09/27/2022
• Initial Report FDA Received Date: 07/05/2022
• Supplement Report FDA Received Date: 10/19/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• 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: Required Intervention; Hospitalization
• Patient Age: 65 YR
• Patient Sex: Female
• Patient Weight: 83 KG