MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH EXETER V40 STEM 44MM NO 2; PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED

Model Number	0580-1-442
Medical Device Problem Codes	Break (1069); Fracture (1260)
Health Effect - Clinical Codes	Bone Fracture(s) (1870); Insufficient Information (4580)
Date of Event	12/13/2022
Type of Reportable Event	Serious Injury
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.
Event or Problem Description
Peroprosthetic break of exeter implant, extremely proximal on trunnion.
Event or Problem Description
Peroprosthetic break of exeter implant, extremely proximal on trunnion.
Additional Manufacturer Narrative
Reported event: an event regarding crack/fracture involving a exeter stem was reported.The event was confirmed via evaluation of the returned device and clinician review of the provided medical records.Method & results: product evaluation and results: visual inspection: visual inspection of the returned device indicated that plastic surface deformation consistent with micro-motion at the stem-cement interface was observed on the surfaces of the stem.This abrasion is indicative of cyclic stress-strain ultimately leading to fatigue fracture of the stem.Clinician review: a review of the provided medical information by a clinical consultant indicated: "this patient underwent a hybrid right total hip arthroplasty and 11 years later required revision for a fracture of the femoral trunnion.I can confirm that the patient had the primary total hip arthroplasty and sustained a fracture of the femoral trunnion since i was able to review the x-rays.I can confirm that the patient underwent the primary and revision operations also because i have reviewed the operation reports.The root cause of this event cannot be determined with certainty.The causes of femoral trunnion failure are multifactorial including surgical technique such as preparation and implantation of the trunnion and femoral head, patient factors such as activity level and bmi, and implant factors." product history review: review of the device history records indicate the 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 fracture of the exeter stem.Visual inspection of the returned device indicated that plastic surface deformation consistent with micro-motion at the stem-cement interface was observed on the surfaces of the stem.This abrasion is indicative of cyclic stress-strain ultimately leading to fatigue fracture of the stem.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.

• Brand Name: EXETER V40 STEM 44MM NO 2
• 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: anna ryan ; raheen business park; limerick, NJ NA ; EI NA ; 2018315000
• MDR Report Key: 16092711
• Report Number: 0002249697-2023-00002
• Device Sequence Number: 6516350
• Product Code: LPH
• UDI-Device Identifier: 04546540153319
• UDI-Public: 04546540153319
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• PMA/510(K) Number: K121308
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2011
• Device Explanted Year: 2022
• Reporter Type: Manufacturer
• Report Source: Other,Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 03/08/2023

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: 06/30/2016
• Device Model Number: 0580-1-442
• Device Catalogue Number: 0580-1-442
• Device Lot Number: G3136799
• 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: 12/13/2022
• Supplement Date Received by Manufacturer: 02/14/2023
• Initial Report FDA Received Date: 01/04/2023
• Supplement Report FDA Received Date: 03/08/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/28/2011
• 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: 82 YR
• Patient Sex: Unknown