MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH EXETER V40(TM). SHORT FEMORAL; PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, CEMENTED

Model Number	0580-1-044
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Codes	Pain (1994); Ambulation or Postural Difficulties (2544)
Date of Event	06/27/2022
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Should additional information become available, it will be provided in a supplemental report upon completion of the investigation.
Event or Problem Description
Patient was seen on (b)(6) 2022 complaining of pain around left hip.Broken stem identified.On (b)(6) 2022- revision - eto and removal of broken stem and cement - revised to restoration stem.Also, removal of poly liner from tritanium shell which was replaced by mdm liner.Left hip.
Additional Manufacturer Narrative
Reported event: an event regarding crack/fracture involving an exeter stem was reported.The event was confirmed through evaluation of the returned device.Method & results: -product evaluation and results: visual inspection was performed as part of the material analysis report (mar), dated (b)(6) 2022.This inspection indicated: visual and stereo-microscope examination on visual examination, the fracture was observed through the mid-stem region, approximately 56 mm from the distal tip.The femoral head remained locked on the stem trunnion.Stereo microscope imaging was performed on both distal and proximal fracture surfaces.The fracture surfaces associated with the proximal and distal sections, respectively.Based on macroscopic surface features observed, including beach marks, the approximate location of origin (o) and direction of propagation (p) were determined.The macroscopic surface features observed on the fracture surface indicate the component fractured due to fatigue.Shows surface material damage on the side of the stem, opposite the origin location and half-way between the fracture surface and the head.Shows surface material damage on the sides of the distal end of the stem.These indications were likely a result of third-body damage and micromotion effects due to cement mantle breakdown.A material analysis has been performed.The report concluded: review of exeter v40 stem, catalogue # 0580-1-044, lot code g7280241 confirmed a fracture in the mid-stem region.Characterisation using stereo microscopy and scanning electron microscopy confirmed the component fractured due to fatigue through the mid-stem region.-clinician review: no medical records were received for review with a clinical consultant.-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.Conclusion: visual inspection was performed as part of the material analysis report (mar), dated (b)(6) 2022.This inspection indicated: visual and stereo-microscope examination on visual examination, the fracture was observed through the mid-stem region, approximately 56 mm from the distal tip.The femoral head remained locked on the stem trunnion.Stereo microscope imaging was performed on both distal and proximal fracture surfaces.The fracture surfaces associated with the proximal and distal sections, respectively.Based on macroscopic surface features observed, including beach marks, the approximate location of origin (o) and direction of propagation (p) were determined.The macroscopic surface features observed on the fracture surface indicate the component fractured due to fatigue.Shows surface material damage on the side of the stem, opposite the origin location and half-way between the fracture surface and the head.Shows surface material damage on the sides of the distal end of the stem.These indications were likely a result of third-body damage and micromotion effects due to cement mantle breakdown.A material analysis has been performed.The report concluded: review of exeter v40 stem, catalogue # 0580-1-044, lot code g7280241 confirmed a fracture in the mid-stem region.Characterisation using stereo microscopy and scanning electron microscopy confirmed the component fractured due to fatigue through the mid-stem region.The exact cause of the event could not be confirmed as insufficient information was provided.Further information such as 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.
Event or Problem Description
Patient was seen (b)(6) 2022 complaining of pain around left hip.Broken stem identified.(b)(6) 2022- revision - eto and removal of broken stem and cement - revised to restoration stem.Also, removal of poly liner from tritanium shell which was replaced by mdm liner.Left hip.

• Brand Name: EXETER V40(TM). SHORT FEMORAL
• 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: marisol santiago ; 325 corporate drive; mahwah, NJ 07430 ; 2018315000
• MDR Report Key: 15083831
• Report Number: 0002249697-2022-01067
• Device Sequence Number: 11792105
• Product Code: JDI
• UDI-Device Identifier: 04546540509048
• UDI-Public: 04546540509048
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• PMA/510(K) Number: K121308
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2018
• Device Explanted Year: 2022
• Reporter Type: Manufacturer
• Report Source: Other,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 10/25/2022

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: 02/28/2023
• Device Model Number: 0580-1-044
• Device Catalogue Number: 0580-1-044
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/08/2022
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 06/27/2022
• Supplement Date Received by Manufacturer: 10/04/2022
• Initial Report FDA Received Date: 07/22/2022
• Supplement Report FDA Received Date: 10/25/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/19/2018
• 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: 85 YR
• Patient Sex: Unknown