MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH EXETER V40 STEM 37.5MM NO 2; PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED

Catalog Number	0580-1-372
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	Ambulation or Postural Difficulties (2544)
Date of Event	05/20/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
It has been reported a patient suffered an intervention whose the exeter rod 0580-1-372 broke and was replaced.The 1st implant (broken one) was implanted in (b)(6) 2021.The broken part is available for evaluation.
Additional Manufacturer Narrative
An evaluation of the device cannot be performed as the device was not returned to the manufacturer.Should additional information become available it will be reported in a supplemental report upon completion of the investigation.
Additional Manufacturer Narrative
Reported event: an event regarding crack/fracture involving an exeter stem was reported.The event was confirmed via evaluation of the returned device.Method & results: product evaluation and results: visual inspection of the returned device indicated in mar report.The image shows the exeter v40 stem with fracture location highlighted.The fracture occurred through the neck of the stem.On visual examination, the fracture was observed approximately 15 mm from the femoral head.Stereo microscope imaging was performed on both the proximal and distal fracture surfaces, respectively.Based on macroscopic surface features observed, including beach marks, the approximate location of origin (o) and direction of propagation were determined.The final fracture (f) location is also identified and labelled.The macroscopic surface features observed on the fracture surface indicate the component fracture propagated in fatigue.Widespread mechanical damage was also observed on the proximal and distal fracture surfaces as well as on the lower hemisphere of the femoral head.Figure shows the side of the stem near the fracture surface on the distal end of the stem, with explantation damage observed.Figure shows evidence of explantation damage near the fracture surface on the distal end of the stem.Clinician review: a review with a clinical consultant indicated " the first x-ray shows a cemented exeter stem in anatomic position without evidence of mechanical complication.The following two x-rays show a cemented exeter stem with a fractured neck fractured neck of a cemented exeter stem is confirmed.The root cause of this complication cannot be determined from the limited documentation provided." 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 fracture of the stem.Characterization using stereo microscopy and scanning electron microscopy confirmed fracture of the stem through the neck.The fracture was observed to have propagated in fatigue with final fracture in overload.No manufacturing or material related defects were observed on the device surfaces examined.A review with a clinical consultant indicated " the first x-ray shows a cemented exeter stem in anatomic position without evidence of mechanical complication.The x-rays show a cemented exeter stem with a fractured neck fractured neck of a cemented exeter stem is confirmed.The root cause of this complication cannot be determined from the limited documentation provided." if additional information becomes available to indicate further evaluation is warranted, this record will be reopened.
Event or Problem Description
It has been reported a patient suffered an intervention whose the exeter rod 0580-1-372 broke and was replaced.The 1st implant (broken one) was implanted on (b)(6) 2021.The broken part is available for evaluation.

• Brand Name: EXETER V40 STEM 37.5MM 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: 19497428
• Report Number: 0002249697-2024-00861
• Device Sequence Number: 6661144
• Product Code: LPH
• UDI-Device Identifier: 04546540153265
• UDI-Public: 04546540153265
• Combination Product (Y/N): N
• Initial Reporter Country: RO
• PMA/510(K) Number: K121308
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2021
• Device Explanted Year: 2024
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 11/15/2024

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: 04/30/2024
• Device Catalogue Number: 0580-1-372
• Device Lot Number: G7645481
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 05/21/2024
• Supplement Date Received by Manufacturer: 10/24/2024
• Initial Report FDA Received Date: 06/10/2024
• Supplement Report FDA Received Date: 11/15/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/24/2019
• 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: Hospitalization; Required Intervention
• Patient Age: 76 YR
• Patient Sex: Male
• Patient Weight: 130 KG