MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH EXETER V40 STEM 35.5MM; PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED

Catalog Number	0580-1-351
Medical Device Problem Codes	Fracture (1260); Loss of Osseointegration (2408)
Health Effect - Clinical Code	Inadequate Osseointegration (2646)
Date of Event	04/16/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
It was noted that the device is not available for evaluation.If additional information is received, it will be provided in a supplemental report upon completion of the investigation.H3 other text : not returned.
Event or Problem Description
Suspecting a stem loosening, the revision of the stem was performed.When the stem was removed, it was found to be broken off in the middle.
Event or Problem Description
Suspecting a stem loosening, the revision of the stem was performed.When the stem was removed, it was found to be broken off in the middle.
Additional Manufacturer Narrative
An event regarding crack/fracture and loosening 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: visual inspection of the returned device indicated that the stem has fractured mid-way through.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 requiring revision.-clinician review: a review of the provided medical information by a clinical consultant indicated: "confirmation of event: i can confirm that the patient had a primary right total hip arthroplasty since i was able to see an x-ray with the implant in place.I cannot confirm that the revision took place since i have no documentation such as doctors notes, operation notes, photos of the explanted prosthesis, or post revision x-rays.Root cause analysis: the root cause of this event cannot be determined with certainty.The causes of femoral loosening with subsequent stem fracture are multifactorial including surgical technique, especially in the cement technique.Despite the grade a cement mantle, the implant may have been better fixed distally than it was approximately causing a micro motion type effect with subsequent stress fracture of the implant.Loosening itself is also multifactorial including surgical technique and local host bone qualities.Patient lifestyle, activity level and bmi also plays a role, as well as possible implant factors." -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 and loosening of the stem.Visual inspection of the returned device indicated that the stem has fractured mid-way through.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 requiring revision.A review of the provided medical information by a clinical consultant indicated the following: "the root cause of this event cannot be determined with certainty.The causes of femoral loosening with subsequent stem fracture are multifactorial including surgical technique, especially in the cement technique.Despite the grade a cement mantle, the implant may have been better fixed distally than it was approximately causing a micro motion type effect with subsequent stress fracture of the implant.Loosening itself is also multifactorial including surgical technique and local host bone qualities.Patient lifestyle, activity level and bmi also plays a role, as well as possible implant factors." 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.

• Brand Name: EXETER V40 STEM 35.5MM
• 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: brad curtis ; 325 corporate drive; mahwah, NJ 07430 ; 2018315000
• MDR Report Key: 19282331
• Report Number: 0002249697-2024-00717
• Device Sequence Number: 7577738
• Product Code: LPH
• UDI-Device Identifier: 04546540153234
• UDI-Public: 04546540153234
• 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: 2020
• Device Explanted Year: 2024
• Reporter Type: Manufacturer
• Report Source: Other,Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 09/06/2024

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: 10/31/2024
• Device Catalogue Number: 0580-1-351
• Device Lot Number: G7716592
• 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: 04/16/2024
• Supplement Date Received by Manufacturer: 08/12/2024
• Initial Report FDA Received Date: 05/09/2024
• Supplement Report FDA Received Date: 09/06/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/02/2019
• 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: 67 YR
• Patient Sex: Female
• Patient Weight: 61 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: Asian