MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH EXETER V40 STEM 44MM NO 0; PROSTHESIS, HIP, SEMI-CONSTRAINED, UNCEMENTED, METAL / POLYMER, NON-POROUS, CALC

Catalog Number	0580-1-440
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	01/04/2024
Type of Reportable Event	Serious Injury
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.H3 other text : not available.
Event or Problem Description
Revision surgery due to broken exeter stem.Stem was revised due to breaking at the calcar/trunnion.Another company was used for the remainder of the procedure.Original surgery performed roughly 15 years ago.
Additional Manufacturer Narrative
Reported event: an event regarding crack/fracture involving an exeter stem was reported.The event was confirmed via provided photographs of the device and clinician review of provided medical records.Method & results: product evaluation and results: the reported device was not returned however photographs were provided for review.The photographs show that the neck of the stem has fractured.Nothing further can be observed as the device appears covered in blood.Clinician review: a review of the provided medical information by a clinical consultant indicated: "i can confirm that the patient had the primary hybrid total hip arthroplasty and sustained a prosthetic fracture of the femoral neck with a well fixed stem since i was able to review and x-ray showing the implant and fracture.Root cause analysis: the root cause of this event cannot be determined with certainty.The causes of femoral stem fracture, approximately 15 years after implantation or multifactorial including surgical technique, especially in the way the implant was cemented (in this case it was well cemented), the patient's activity level and bmi, about which we have no information, 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 fracture of the exeter stem.The reported device was not returned however photographs were provided for review.The photographs show that the neck of the stem has fractured.Nothing further can be observed as the device appears covered in blood.The event was further confirmed by a review of the provided x-ray image by a clinical consultan: "i can confirm that the patient had the primary hybrid total hip arthroplasty and sustained a prosthetic fracture of the femoral neck with a well fixed stem since i was able to review and x-ray showing the implant and fracture.Root cause analysis: the root cause of this event cannot be determined with certainty.The causes of femoral stem fracture, approximately 15 years after implantation or multifactorial including surgical technique, especially in the way the implant was cemented (in this case it was well cemented), the patient's activity level and bmi, about which we have no information, and implant factors." further information such as return of the device and office notes/patient history are needed to investigate 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.
Event or Problem Description
Revision surgery due to broken exeter stem.Stem was revised due to breaking at the calcar/trunnion.Another company was used for the remainder of the procedure.Original surgery performed roughly 15 years ago.

• Brand Name: EXETER V40 STEM 44MM NO 0
• Common Device Name: PROSTHESIS, HIP, SEMI-CONSTRAINED, UNCEMENTED, METAL / POLYMER, NON-POROUS, CALC
• 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: 18586109
• Report Number: 0002249697-2024-00139
• Device Sequence Number: 7021539
• Product Code: MEH
• UDI-Device Identifier: 04546540153296
• UDI-Public: 04546540153296
• Combination Product (Y/N): N
• Initial Reporter Country: NZ
• PMA/510(K) Number: K121308
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2009
• Device Explanted Year: 2024
• Reporter Type: Manufacturer
• Report Source: Other,Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 05/27/2024

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 Catalogue Number: 0580-1-440
• 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: 01/04/2024
• Supplement Date Received by Manufacturer: 05/22/2024
• Initial Report FDA Received Date: 01/26/2024
• Supplement Report FDA Received Date: 05/27/2024
• 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: Hospitalization; Required Intervention
• Patient Sex: Unknown