MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH EXETER V40 STEM 44MM NO 1; PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED

Catalog Number	0580-1-441
Medical Device Problem Codes	Fracture (1260); Detachment of Device or Device Component (2907)
Health Effect - Clinical Codes	Discomfort (2330); Ambulation or Postural Difficulties (2544)
Date of Event	11/13/2023
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
Catastrophic failure of exeter stem used in tha.Primary operation 2020 for oa.When patient was bending over in chair, had discomfort in left hip.Able to mobilise after, watering garden, walking, suddenly felt it 'give way'.Wound healed.
Additional Manufacturer Narrative
Reported event: an event regarding crack/fracture and disassociation involving an exeter stem was reported.The event was confirmed via 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 patient sustained a head neck disassociation with trunnion failure approximately three to four years following implantation.I can confirm that the patient had a primary left total hip arthroplasty and sustained a head neck disassociation since i was able to see x-rays showing the implant in place.Revision surgery was planned but i cannot confirm that the procedure occurred.The root cause of head neck disassociation cannot be determined with certainty in this case.The causes are multifactorial including surgical technique, patient factors such as activity level and bmi, and implant factors." 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 referenced.Conclusions: it was reported that the patient was revised due to failure of the stem neck.A review of the provided medical information by a clinical consultant indicated the following: "this patient sustained a head neck disassociation with trunnion failure approximately three to four years following implantation.I can confirm that the patient had a primary left total hip arthroplasty and sustained a head neck disassociation since i was able to see x-rays showing the implant in place.Revision surgery was planned but i cannot confirm that the procedure occurred.The root cause of head neck disassociation cannot be determined with certainty in this case.The causes are multifactorial including surgical technique, patient factors such as activity level and bmi, and implant factors." the reviewing clinician further stated that "it appears that the trunnion has fractured with a deformity present" from the ct scan image that was shared.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
Catastrophic failure of exeter stem used in tha.Primary operation 2020 for oa.When patient was bending over in chair, had discomfort in left hip.Able to mobilise after, watering garden, walking, suddenly felt it 'give way'.Wound healed.Update: clinician review of the provided x-ray and ct scan images indicated that head neck disassociation and trunnion fracture had occurred.

• Brand Name: EXETER V40 STEM 44MM NO 1
• Common Device Name: PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED
• 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: 18284672
• Report Number: 0002249697-2023-01508
• Device Sequence Number: 15165294
• Product Code: LPH
• UDI-Device Identifier: 04546540153302
• UDI-Public: 04546540153302
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• PMA/510(K) Number: K011623
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2020
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 03/21/2024

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 Expiration Date: 10/31/2024
• Device Catalogue Number: 0580-1-441
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 11/14/2023
• Supplement Date Received by Manufacturer: 02/26/2024
• Initial Report FDA Received Date: 12/07/2023
• Supplement Report FDA Received Date: 03/21/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 10/17/2019
• 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: Other
• Patient Age: 76 YR
• Patient Sex: Unknown
• Patient Weight: 130 KG