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

Model Number	0580-1-351
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Codes	Ambulation or Postural Difficulties (2544); Insufficient Information (4580)
Date of Event	10/21/2021
Type of Reportable Event	Serious Injury
Event or Problem Description
Broken exeter stem.Revision procedure booked for possibly (b)(6) 2021.
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.
Additional Manufacturer Narrative
Reported event: an event regarding crack/fracture involving a exeter stem was reported.The event was confirmed through clinician review of the provided medical records.Method & results: -product evaluation and results: no product was returned for evaluation however a photograph was attached.The photograph shows an exeter stem with a head attached.The stem is fractured in half.-clinician review: a review of the provided medical records by a clinical consultant indicated: this inquiry reports the failure of a cemented femoral stem due to fracture.I can confirm that this event took place since i was able to see photos of the explanted device and xrays of the fractured stem.I was not able to see a revision operation report.Regarding the possible root cause of this event, i cannot determine it with certainty.Causes of femoral stem fracture or multi factorial including surgical technique factors, patient factors such as activity level and bmi, and implant factors.If an implant is well fixed distally and not well fixed proximally micromotion can occur which can result in fracture.The implant would have to be examined by a metallurgical expert to determine the type of fracture.-device history review: could not be performed as lot code information was not provided.-complaint history review: could not be performed as lot code information was not provided.Conclusion: a review of the provided medical records by a clinical consultant indicated: this inquiry reports the failure of a cemented femoral stem due to fracture.I can confirm that this event took place since i was able to see photos of the explanted device and xrays of the fractured stem.I was not able to see a revision operation report.Regarding the possible root cause of this event, i cannot determine it with certainty.Causes of femoral stem fracture or multi factorial including surgical technique factors, patient factors such as activity level and bmi, and implant factors.If an implant is well fixed distally and not well fixed proximally micromotion can occur which can result in fracture.The implant would have to be examined by a metallurgical expert to determine the type of fracture.No further investigation is required at this time.If additional information becomes available to indicate further evaluation is warranted, this record will be reopened.
Event or Problem Description
Broken exeter stem.Revision procedure booked for possibly (b)(6) 2021.

• 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: arokiya raj ; 325 corporate drive; mahwah, NJ 07430 ; 2018315000
• MDR Report Key: 12813628
• Report Number: 0002249697-2021-01892
• Device Sequence Number: 17332546
• Product Code: LPH
• UDI-Device Identifier: 04546540153234
• UDI-Public: 04546540153234
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• PMA/510(K) Number: K011623
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Explanted Year: 2021
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 04/04/2022

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 Model Number: 0580-1-351
• Device Catalogue Number: 0580-1-351
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 10/21/2021
• Supplement Date Received by Manufacturer: 03/23/2022
• Initial Report FDA Received Date: 11/15/2021
• Supplement Report FDA Received Date: 04/04/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• 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 Sex: Male