MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH EXETER V40 STEM 30MM; PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, CEMENTED

Model Number	0580-1-300
Medical Device Problem Codes	Loss of Osseointegration (2408); Device Dislodged or Dislocated (2923)
Health Effect - Clinical Codes	Pain (1994); Joint Dislocation (2374); Inadequate Osseointegration (2646)
Date of Event	06/20/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
Revision thr.According to the complainant the exeter was explanted from the patient.Patient complaint of pain and loosing of implant.
Additional Manufacturer Narrative
Review of the device history records indicate devices were manufactured and accepted into final stock with no relevant reported discrepancies.There have been no other similar events for the lot referenced.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 : device not returned.
Event or Problem Description
Revision thr.According to the complainant the exeter was explanted from the patient.Patient complaint of pain and loosing of implant.
Additional Manufacturer Narrative
Reported event: an event regarding loosening involving an exeter stem was reported.The event was not confirmed.Method & results: device evaluation and results: the reported device was not returned however photographs were provided for review.The photographs show a recently explanted exeter stem with nothing remarkable to report.The photograph confirms the lot code.Material analysis, functional and dimensional inspections could not be performed as the device was not returned.Clinician review: a review of the provided medical records by a clinical consultant stated the following: 'this patient underwent a left total hip arthroplasty with a cementless cup and a cemented exeter stem.Approximately 10 years after implantation the patient developed pain and a revision was carried out on (b)(6), 2023.The implant was found to be loose.I can confirm that the primary total hip arthroplasty occurred since i was able to view xrays of the implant in place.I cannot confirm that the revision occurred since i have no documentation such as office notes, operation notes or post revision x-rays.The root cause of this event cannot be determined with certainty.The causes of femoral loosening of a cemented stem at 10 years after surgery are multifactorial including surgical technique factors including cementing technique, patient factors including activity level in bmi.According to the information given i have no cause to assign causality to the implant itself.The explanted prosthesis should be submitted to stryker engineers for examination and evaluation.' device history review: all 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.Conclusion: a review of the provided medical records by a clinical consultant indicated: 'the causes of femoral loosening of a cemented stem at 10 years after surgery are multifactorial including surgical technique factors including cementing technique, patient factors including activity level in bmi.According to the information given i have no cause to assign causality to the implant itself.' further information such as return of the device, pre- and post-operative x-rays, primary 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 additional information become available to indicate further evaluation is warranted, this record will be reopened.

• Brand Name: EXETER V40 STEM 30MM
• 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: anna ryan ; raheen business park; limerick NA ; EI NA ; 61498200
• MDR Report Key: 17330150
• Report Number: 0002249697-2023-00777
• Device Sequence Number: 5536951
• Product Code: JDI
• UDI-Device Identifier: 04546540153210
• UDI-Public: 04546540153210
• Combination Product (Y/N): N
• Initial Reporter Country: MY
• PMA/510(K) Number: K173499
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2013
• Device Explanted Year: 2023
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 08/04/2023

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: 01/31/2012
• Device Model Number: 0580-1-300
• Device Catalogue Number: 0580-1-300
• Device Lot Number: G1711082
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 06/20/2023
• Supplement Date Received by Manufacturer: 07/19/2023
• Initial Report FDA Received Date: 07/14/2023
• Supplement Report FDA Received Date: 08/04/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 01/26/2007
• 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: 69 YR
• Patient Sex: Male