MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH EXETER V40 STEM 33MM; PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED

Model Number	0580-1-330
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Codes	Discomfort (2330); Ambulation or Postural Difficulties (2544)
Date of Event	02/20/2023
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.Device not returned to the manufacturer.
Event or Problem Description
There were no problems after the operation seven years ago but when the patient complained of femoral discomfort, a check revealed a broken stem.
Additional Manufacturer Narrative
Reported event: an event regarding crack/fracture involving a exeter stem was reported.The event was confirmed via clinician review of the provided medical records.Method & results: visual inspection of the returned device was performed as part of the material analysis: "image depicted shows the exeter v40 stem with fracture location highlighted.On visual examination, the fracture was observed through the mid-stem region, approximately 70 mm from the distal tip." material analysis: a material analysis was performed and concluded the following: "review of exeter v40 stem 33mm, catalog # 0580-1-330, lot code g3915027 confirmed fracture of the stem.Characterization using stereo microscopy and scanning electron microscopy confirmed fracture of the stem through the mid-stem region.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.Clinician review: a review of the provided medical records by a clinical consultant stated the following comment: "there were no problems after the operation seven years ago but when the patient complained of femoral discomfort, a check revealed a broken stem.On the lateral x-ray a small fracture is identified at the mid -stem level lateral aspect.This fracture is not seen on the ap x-ray.There is no evidence of stem fixation loss and the stem appears well supported and fixed.Fracture of an apparently well-fixed femoral stem component is confirmed.The root cause of this fracture cannot be identified from this limited documentation, should additional information become available i would be happy to further this assessment." 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 fractured stem.Visual inspection of the returned device was performed as part of the material analysis: "image depicted shows the exeter v40 stem with fracture location highlighted.On visual examination, the fracture was observed through the mid-stem region, approximately 70 mm from the distal tip.A material analysis was performed and concluded the following: "review of exeter v40 stem 33mm, catalog # 0580-1-330, lot code g3915027 confirmed fracture of the stem.Characterization using stereo microscopy and scanning electron microscopy confirmed fracture of the stem through the mid-stem region.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 of the provided medical records by a clinical consultant stated the following comment: "there were no problems after the operation seven years ago but when the patient complained of femoral discomfort, a check revealed a broken stem.On the lateral x-ray a small fracture is identified at the mid -stem level lateral aspect.This fracture is not seen on the ap x-ray.There is no evidence of stem fixation loss and the stem appears well supported and fixed.Fracture of an apparently well-fixed femoral stem component is confirmed.The root cause of this fracture cannot be identified from this limited documentation, should additional information become available i would be happy to further this assessment." 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.
Event or Problem Description
There were no problems after the operation seven years ago but when the patient complained of femoral discomfort, a check revealed a broken stem.

• Brand Name: EXETER V40 STEM 33MM
• 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: 16552949
• Report Number: 0002249697-2023-00273
• Device Sequence Number: 5088586
• Product Code: LPH
• UDI-Device Identifier: 04546540153227
• UDI-Public: 04546540153227
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K011623
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2015
• Device Explanted Year: 2023
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 08/17/2023

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: 11/30/2018
• Device Model Number: 0580-1-330
• Device Catalogue Number: 0580-1-330
• Device Lot Number: G3915027
• 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: 02/20/2023
• Supplement Date Received by Manufacturer: 08/01/2023
• Initial Report FDA Received Date: 03/16/2023
• Supplement Report FDA Received Date: 08/17/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/15/2013
• 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: Female
• Patient Weight: 80 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: Asian