MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH EXETER V40 STEM 37.5MM NO 1; PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED

Catalog Number	0580-1-371
Medical Device Problem Code	Malposition of Device (2616)
Health Effect - Clinical Code	Joint Dislocation (2374)
Date of Event	10/26/2023
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.H3 other text : device not returned to the manufacturer.
Event or Problem Description
Tha was performed for left hip of the female patient on (b)(6), 2023.The revision surgery was performed on (b)(6), 2023 because of frequent dislocations.Accidently, the exeter v40 stem and the delta v40 ceramic head were implanted in combination in the revision surgery.The surgeon decides that the stem and the head are left as they are in the patient's hip and will keep monitoring.The issue was that the cup with the liner was come off (dislocated) while the head was fixed to the stem.Because the doctor took into consideration the fact that the cup was installed at an incorrect angle and the anteversion angle of the stem was too sharp, the entire implant products, including not only the cup and liner but also the head and stem, were replaced.This record was opened for revision surgery by frequent dislocations and incorrect combination implantation in the revision surgery was opened in another record.
Additional Manufacturer Narrative
Reported event: an event regarding malposition involving an exeter stem was reported.The event was not confirmed.Method & results: product evaluation and results: material analysis, visual, functional and dimensional inspections could not be performed as the device was not returned.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 the cup with the liner was come off (dislocated).The shell and stem were revised as they were installed in the incorrect position.The exact cause of the event could not be determined because insufficient information was provided.Further information such as pathology reports, 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
Tha was performed for left hip of the female patient on (b)(6) 2023.The revision surgery was performed on (b)(6) 2023 because of frequent dislocations.Accidently, the exeter v40 stem and the delta v40 ceramic head were implanted in combination in the revision surgery.The surgeon decides that the stem and the head are left as they are in the patient's hip and will keep monitoring.The issue was that the cup with the liner was come off (dislocated) while the head was fixed to the stem.Because the doctor took into consideration the fact that the cup was installed at an incorrect angle and the anteversion angle of the stem was too sharp, the entire implant products, including not only the cup and liner but also the head and stem, were replaced.This record was opened for revision surgery by frequent dislocations and incorrect combination implantation in the revision surgery was opened in another record.

• Brand Name: EXETER V40 STEM 37.5MM NO 1
• 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: 18144495
• Report Number: 0002249697-2023-01416
• Device Sequence Number: 17861106
• Product Code: LPH
• UDI-Device Identifier: 04546540153258
• UDI-Public: 04546540153258
• 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: 2023
• Device Explanted Year: 2023
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 03/21/2024

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 Catalogue Number: 0580-1-371
• Device Lot Number: G8356612
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: Not provided
• Supplement Date Received by Manufacturer: 02/26/2024
• Initial Report FDA Received Date: 11/15/2023
• Supplement Report FDA Received Date: 03/21/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 01/18/2022
• 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: Female
• Patient Weight: 50 KG