MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH EXETER V40 STEM 37.5MM NO 0; PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED

Catalog Number	0580-1-352
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Codes	Ambulation or Postural Difficulties (2544); Insufficient Information (4580)
Date of Event	06/29/2024
Type of Reportable Event	Serious Injury
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.
Event or Problem Description
It was reported that the patients x-ray showed a fractured stem.Patient presented to emergency (b)(6)2024.It was further reported that "patient required revision hip arthroplasty with femoral osteotomy, cement removal.Poly liner changed and new restoration modular stem implantation with 5 dall miles cables.".
Additional Manufacturer Narrative
Reported event: an event regarding crack/fracture involving an exeter stem was reported.The event was confirmed via clinician review of the provided medical records and evaluation of the returned device.Method & results: -product evaluation and results: visual inspection of the returned device indicated that the stem has fractured mid-way.Surface deformation consistent with micro-motion at the stem-cement interface was observed on the surfaces of the stem.The damage is consistent with fatigue accumulation in the stem as ultimately ending in a fatigue fracture of the stem.-clinician review: a review of the provided medical information by a clinical consultant indicated: ""conclusion/assessment: no medical records were provided for review other than unlabeled and undated x-rays.The x-rays show a fractured exeter style stem with the proximal segment in marked varus.The distal segment looks stable.The cup looks stable.Another x-ray shows a stable construct presumably predating the fracture.No revision data was provided for review.A revision would be required as noted in the pi report.Event confirmation: the event, a stem fracture, can be confirmed.Revision surgery cannot be confirmed but would be expected.Root cause: the root cause of the reported revision (not confirmed) would be the stem fracture.The root cause of the stem failure cannot be ascertained." -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 is planned to be revised due to fracture of the stem.Visual inspection of the returned device indicated that the stem has fractured mid-way.Surface deformation consistent with micro-motion at the stem-cement interface was observed on the surfaces of the stem.The damage is consistent with fatigue accumulation in the stem as ultimately ending in a fatigue fracture of the stem."conclusion/assessment: no medical records were provided for review other than unlabeled and undated x-rays.The x-rays show a fractured exeter style stem with the proximal segment in marked varus.The distal segment looks stable.The cup looks stable.Another x-ray shows a stable construct presumably predating the fracture.No revision data was provided for review.A revision would be required as noted in the pi report.Event confirmation: the event, a stem fracture, can be confirmed.Revision surgery cannot be confirmed but would be expected.Root cause: the root cause of the reported revision (not confirmed) would be the stem fracture.The root cause of the stem failure cannot be ascertained." 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
It was reported that the patients x-ray showed a fractured stem.Patient presented to emergency (b)(6), 2024.It was further reported that "patient required revision hip arthroplasty with femoral osteotomy, cement removal.Poly liner changed and new restoration modular stem implantation with 5 dall miles cables.".

• Brand Name: EXETER V40 STEM 37.5MM NO 0
• 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: 19871952
• Report Number: 0002249697-2024-01056
• Device Sequence Number: 15229811
• Product Code: LPH
• UDI-Device Identifier: 04546540153241
• UDI-Public: 04546540153241
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• PMA/510(K) Number: K011623
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Explanted Year: 2024
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 10/09/2024

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: 06/30/2025
• Device Catalogue Number: 0580-1-352
• Device Lot Number: G7908950
• 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: 07/04/2024
• Supplement Date Received by Manufacturer: 09/17/2024
• Initial Report FDA Received Date: 07/31/2024
• Supplement Report FDA Received Date: 10/09/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/08/2020
• 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: 66 YR
• Patient Sex: Male
• Patient Weight: 112 KG