MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH EXETER V40 STEM 44MM NO 0; PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED

Catalog Number	0580-1-440
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Codes	Fall (1848); Pain (1994); Insufficient Information (4580)
Date of Event	11/21/2023
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
Sales rep report: "i don't have much information yet but would like to report a broken exeter stem.The stem is currently being decontaminated so if you can provide a returns number i'll get it back to you when it is ready, please? surgery (b)(6) 2023 - revision of primary exeter stem due to it breaking around neck area.".
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: visual inspection of the returned device indicated that surface deformation is 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 requiring revision.-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.Conclusions: it was reported that the patient was revised due to fracture of the stem.Visual inspection of the returned device indicated that surface deformation is 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 requiring revision.Further information such as pre- and post-operative x-rays and the revision 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 becomes available to indicate further evaluation is warranted, this record will be reopened.
Event or Problem Description
Sales rep report: "i don't have much information yet but would like to report a broken exeter stem.The stem is currently being decontaminated so if you can provide a returns number i'll get it back to you when it is ready, please? surgery (b)(6) 2023 - revision of primary exeter stem due to it breaking around neck area.".
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: visual inspection of the returned device indicated that surface deformation is 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 requiring revision.Clinician review: a review of the provided medical records by a clinical consultant indicated: "confirmation of event: i can confirm that the patient had primary simultaneous bilateral hybrid total hip arthroplasties on (b)(6) 2019, and revision surgery for a fracture of the femoral stem on (b)(6) 2023 since i was able to review both operation reports.I was not able to review any x-rays since none were provided.Root cause analysis: the root cause of this event cannot be determined with certainty.Causes of implant femoral neck fracture 4 1/2 years following initial surgery are multifactorial.They include surgical factors including surgical technique, especially in the placement and positioning of the femoral component, the quality and technique of cement insertion and component insertion, patient factors including lifestyle, activity level and bmi as well as implant factors.This patient has a bmi which would place her in a category of being obese and obesity plays a role in implant fractures.The surgeon elected to use a competitor cement which could also play a role." 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.Visual inspection of the returned device indicated that surface deformation is 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 requiring revision.A review of the provided medical records by a clinical consultant indicated: "confirmation of event: i can confirm that the patient had primary simultaneous bilateral hybrid total hip arthroplasties on (b)(6) 2019, and revision surgery for a fracture of the femoral stem on (b)(6) 2023 since i was able to review both operation reports.I was not able to review any x-rays since none were provided.Root cause analysis: the root cause of this event cannot be determined with certainty.Causes of implant femoral neck fracture 4 1/2 years following initial surgery are multifactorial.They include surgical factors including surgical technique, especially in the placement and positioning of the femoral component, the quality and technique of cement insertion and component insertion, patient factors including lifestyle, activity level and bmi as well as implant factors.This patient has a bmi which would place her in a category of being obese and obesity plays a role in implant fractures.The surgeon elected to use a competitor cement which could also play a role." 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
Sales rep report: "i don't have much information yet but would like to report a broken exeter stem.The stem is currently being decontaminated so if you can provide a returns number i'll get it back to you when it is ready, please? surgery (b)(6) 2023 - revision of primary exeter stem due to it breaking around neck area." right hip.

• Brand Name: EXETER V40 STEM 44MM 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: sanjana talathi ; 325 corporate drive; mahwah, NJ 07430 ; 2018315000
• MDR Report Key: 18307854
• Report Number: 0002249697-2023-01541
• Device Sequence Number: 6717911
• Product Code: LPH
• UDI-Device Identifier: 04546540153296
• UDI-Public: 04546540153296
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• PMA/510(K) Number: K011623
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2019
• Device Explanted Year: 2023
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 02/17/2025

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: 10/31/2023
• Device Catalogue Number: 0580-1-440
• Device Lot Number: G7536825
• 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: 11/24/2023
• Supplement Date Received by Manufacturer: 03/07/2024; 01/21/2025
• Initial Report FDA Received Date: 12/11/2023
• Supplement Report FDA Received Date: 04/02/2024; 02/18/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/29/2018
• 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: 50 YR
• Patient Sex: Female
• Patient Weight: 79 KG