MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH EXETER V40 STEM 50MM NO 1; PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, CEMENTED

Model Number	0580-3-501
Medical Device Problem Codes	Break (1069); Fracture (1260)
Health Effect - Clinical Codes	Ambulation or Postural Difficulties (2544); Insufficient Information (4580)
Date of Event	05/05/2021
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.
Event or Problem Description
On the 5th of may the patient was cooking in the kitchen.The patient turned around and dropped through his leg or slipped.Patient immediately wasn¿t able anymore to load the left leg.Patient was brought in with the ambulance.Patient has a broken exeter stem.
Additional Manufacturer Narrative
An event regarding crack/fracture involving an exeter stem was reported.The event was confirmed via evaluation of the returned device and review of the provided medical records by a clinical consultant.Method & results: -product evaluation and results: visual inspection: visual inspection of the returned device indicated that the stem is fractured at the neck.Scratches and marks are observed along the body of the device.Material analysis: a material analysis was performed and concluded the following: "the implanted device underwent cyclic stresses that were exacerbated by micromotion movement of the stem within the securing surgical cement.The evidence is consistent with fatigue fracture advancement occurring until the stem became unstable and fractured from stress overload." -clinician review: a review of the provided medical records by a clinical consultant indicated: "as described above the patient sustained a fracture/disassociation of the femoral trunnion of a cemented exeter prosthesis.This occurred approximately 2 1/2 years after implantation.All components were well fixed without any abnormality.I can confirm that the event occurred since i was able to see an x-ray demonstrating the failure of the exeter implant.I do not have documentation of the revision except for in the summary cover sheet that states that the implant was removed on (b)(6) 2021.The root cause of trunnion failure is multifactorial including surgical technique factors, patient factors such as activity level and bmi (the patient was obese) and implant factors." -product history review: could not be performed as lot code information was unknown.-complaint history review: could not be performed as lot code information was unknown.Conclusions: it was reported that the patient was revised due to fracture of the exeter stem.Visual inspection of the returned device indicated that the stem is fractured at the neck.Scratches and marks are observed along the body of the device.A material analysis was performed and concluded the following: "the implanted device underwent cyclic stresses that were exacerbated by micromotion movement of the stem within the securing surgical cement.1 the evidence is consistent with fatigue fracture advancement occurring until the stem became unstable and fractured from stress overload." the event was further confirmed by a clinical clinician's review of the provided x-ray image.The exact cause of the event could not be determined from the information provided; however, it is possible that the reported patient fall/slip contributed to the fracture.The patient was also reported to be obese, and per the ifu, the heavier the patient, the greater the load on the prosthesis.As the loads on the prosthesis increase, the chance a patient will suffer adverse reactions increases.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.
Event or Problem Description
On the (b)(6)the patient was cooking in the kitchen.The patient turned around and dropped through his leg or slipped.Patient immediately wasn¿t able anymore to load the left leg.Patient was brought in with the ambulance.Patient has a broken exeter stem.

• Brand Name: EXETER V40 STEM 50MM NO 1
• 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: joann ripoli ; 325 corporate drive; mahwah, NJ 07430 ; 2018315000
• MDR Report Key: 11912619
• Report Number: 0002249697-2021-00954
• Device Sequence Number: 14481464
• Product Code: JDI
• UDI-Device Identifier: 04546540153364
• UDI-Public: 04546540153364
• Combination Product (Y/N): N
• Initial Reporter Country: NL
• PMA/510(K) Number: K121308
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2018
• Device Explanted Year: 2021
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 08/12/2022

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: 0580-3-501
• Device Catalogue Number: 0580-1-501
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 05/07/2021
• Supplement Date Received by Manufacturer: 07/19/2022
• Initial Report FDA Received Date: 06/01/2021
• Supplement Report FDA Received Date: 08/12/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• 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: 72 YR
• Patient Sex: Male
• Patient Weight: 89 KG