MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH EXETER V40 STEM 37.5MM NO 2; PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED

Model Number	0580-1-372
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	Fall (1848)
Date of Event	08/10/2022
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.
Event or Problem Description
It has been reported "we received information about a broken stryker implant, namely, the exeter leg broke in the patient.Patient fell on the street, after which a fracture occurred (exeter leg broke).The patient turned himself to the clinic, as the primary operation was performed in the same medical facility".
Additional Manufacturer Narrative
Reported event: an event regarding crack/fracture involving an exeter stem was reported.The event was confirmed via clinician review of provided medical records.Method & results: -product evaluation and results: visual inspection, dimensional, functional and material analysis could not be performed as the device was not returned.-clinician review: a review of the provided medical information by a clinical consultant indicated: the ap pelvis x-ray demonstrates a cemented left total hip.There is a transverse fracture through the neck of the femoral stem.The head and portion of the neck are displaced from the stem.It is confirmed that a fracture through the neck of a cemented femoral stem has occurred.The root cause of this mechanical complication cannot be determined from this limited documentation.Should additional information become available i would be happy to further this assessment." -product history review: review of the device history records could not be performed because the lot code provided is invalid.-complaint history review: a complaint history review could not be performed as lot code information was invalid.Conclusions: it was reported that the patient was revised due to fracture of the exeter stem.The fracture event was further confirmed by a review of the provided medical information by a clinical consultant.Further information such as return of the device is needed to investigate root cause.It was reported that the patient fell, and this trauma event likely contributed to the device failure.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
It has been reported "we received information about a broken stryker implant, namely, the exeter leg broke in the patient.Patient fell on the street, after which a fracture occurred (exeter leg broke).The patient turned himself to the clinic, as the primary operation was performed in the same medical facility".

• Brand Name: EXETER V40 STEM 37.5MM NO 2
• 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: diana rogers ; 210 centennial avenue; centennial park, elstree; borehamwood WD6 3-SJ ; UK WD6 3SJ ; 2082386500
• MDR Report Key: 15347103
• Report Number: 0002249697-2022-01296
• Device Sequence Number: 17286858
• Product Code: LPH
• UDI-Device Identifier: 04546540153265
• UDI-Public: 04546540153265
• Combination Product (Y/N): N
• Initial Reporter Country: RS
• PMA/510(K) Number: K173499
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2019
• Device Explanted Year: 2022
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 11/29/2022

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: 0580-1-372
• Device Catalogue Number: 0580-1-372
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 08/10/2022
• Supplement Date Received by Manufacturer: 11/05/2022
• Initial Report FDA Received Date: 09/02/2022
• Supplement Report FDA Received Date: 11/29/2022
• 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: Required Intervention; Hospitalization
• Patient Age: 75 YR
• Patient Sex: Female
• Patient Weight: 97 KG