MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH EXETER V40 STEM 44MM NO 0; PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, CEMENTED

Catalog Number	0580-1-440
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	07/21/2023
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.
Event or Problem Description
As described by patient: "i had a hip replacement.The joint ¿failed¿ this year.The consultants at the hospital where i had the hip revision done mentioned that the original hip was made by stryker.I¿m really keen to understand the cause of the failure, there was no trauma, accident or fall involved.Going up the stairs to bed my right leg ¿gave way¿.What information do i need to provide you with so that you can identify the implant and help me understand the cause of the failure? i¿m in the latter stages of my recovery from the procedure but it¿s been a long haul and i am really keen to avoid any repetition of this failure." update per response: issue occurred "going up the stairs to bed my right leg ¿gave way¿ with no fall or other trauma".
Additional Manufacturer Narrative
Corrected data: upon further review, this report has been identified as a duplicate of mfr# 0002249697-2023-00919.All further reporting will be provided under the original mdr# 0002249697-2023-00919.
Event or Problem Description
As described by patient: "i had a hip replacement.The joint ¿failed¿ this year.The consultants at the hospital where i had the hip revision done mentioned that the original hip was made by stryker.I¿m really keen to understand the cause of the failure, there was no trauma, accident or fall involved.Going up the stairs to bed my right leg ¿gave way¿.What information do i need to provide you with so that you can identify the implant and help me understand the cause of the failure? i¿m in the latter stages of my recovery from the procedure but it¿s been a long haul and i am really keen to avoid any repetition of this failure." update per response: issue occurred "going up the stairs to bed my right leg ¿gave way¿ with no fall or other trauma".

• Brand Name: EXETER V40 STEM 44MM NO 0
• 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: anna ryan ; raheen business park; limerick NA ; EI NA ; 61498200
• MDR Report Key: 18044008
• Report Number: 0002249697-2023-01297
• Device Sequence Number: 20852528
• Product Code: JDI
• UDI-Device Identifier: 04546540153296
• UDI-Public: 04546540153296
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• PMA/510(K) Number: K173499
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Consumer
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 02/20/2024

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: 0580-1-440
• Device Lot Number: G7720383
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: Not provided
• Supplement Date Received by Manufacturer: 02/19/2023
• Initial Report FDA Received Date: 10/31/2023
• Supplement Report FDA Received Date: 02/20/2024
• 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: Unknown