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

Model Number	0580-1-562
Medical Device Problem Codes	Fracture (1260); Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	Ambulation or Postural Difficulties (2544)
Date of Event	07/09/2021
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.The following devices were also listed in this report: delta v-40 ceramic head 36/+7,5; cat # 6570-0-736; lot # 58061601.It cannot be determined which, if any of these devices may have caused or contributed to the patient's experience.
Event or Problem Description
Patient reported he slipped and his hip gave way.He mentioned he did not fall but after the slip he couldn't put any weight on his right leg.The patient was admitted to hospital for a revision hip to be completed.Cup and insert remained untouched.Stem and head were revised.
Additional Manufacturer Narrative
Reported event: an event regarding crack/fracture involving an exeter stem was reported.The event was confirmed via provided photos and clinician review.Method & results product evaluation and results: the reported device was not returned however photographs were provided for review.The stem was fractured at neck area.Clinician review: a review of the provided medical information by a clinical consultant indicated: no clinical or pmh, no operative reports, no examination of explanted components or fracture surfaces.While the x-ray and specimen photos appear to confirm the event description, insufficient data is presented to create a medical report for this case.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 slipped and his hip gave way.His hip was revised due to stem fracture.The reported device was not returned however photographs were provided for review.The stem was fractured at neck area.Clinician review of provided medical records also confirmed the event.The exact cause of the event could not be determined because insufficient information was provided.Further information such as return of the device, pathology reports and operative reports 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 devices and / or additional information become available to indicate further evaluation is warranted, this record will be reopened.
Event or Problem Description
Patient reported he slipped and his hip gave way.He mentioned he did not fall but after the slip he couldn't put any weight on his right leg.The patient was admitted to hospital for a revision hip to be completed.Cup and insert remained untouched.Stem and head were revised.Update on 01-oct-2021: the event is about stem fracture.

• Brand Name: EXETER V40(TM). FEMORAL STEM
• 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: 12283267
• Report Number: 0002249697-2021-01314
• Device Sequence Number: 3612215
• Product Code: JDI
• UDI-Device Identifier: 07613327123746
• UDI-Public: 07613327123746
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• PMA/510(K) Number: K173499
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2011
• Device Explanted Year: 2021
• Reporter Type: Manufacturer
• Report Source: Other,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 11/05/2021

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: 09/30/2014
• Device Model Number: 0580-1-562
• Device Catalogue Number: 0580-1-562
• Device Lot Number: G2925617
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 07/09/2021
• Supplement Date Received by Manufacturer: 10/15/2021
• Initial Report FDA Received Date: 08/05/2021
• Supplement Report FDA Received Date: 11/07/2021
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 10/05/2009
• 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: 61 YR
• Patient Sex: Male
• Patient Weight: 160 KG