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

Catalog Number	0580-1-351
Medical Device Problem Codes	Fracture (1260); Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	12/21/2021
Type of Reportable Event	Serious Injury
Event or Problem Description
Revision surgery.
Additional Manufacturer Narrative
Review of the device history records indicate devices were manufactured and accepted into final stock with no relevant reported discrepancies.There have been no other similar events for the lot referenced.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: trident hemispherical cluster hole shell; cat # 502-11-54e; lot # 56334203.6.5 cancellous bone screw 35mm; cat # 2030-6535-1; lot # rr2tkv.6.5 cancellous bone screw 25mm; cat # 2030-6525-1; lot # 744y3w.Exeter v40 stem 35.5mm; cat # 0580-1-351; lot # g6106164.Exeter 2.5 i m plug 8mm; cat # 09390108; lot # u81s7 l7871.32mm std lfit v40 head; cat # 6260-9-132; lot # 57184806.It cannot be determined which, if any of these devices may have caused or contributed to the patient's experience.H3 other text : not available.
Additional Manufacturer Narrative
Update to: the following devices were also listed in this report: simplex tobramycin 1 pk; cat # 61971001; lot # tlx044, qty: 2.It cannot be determined which, if any of these devices may have caused or contributed to the patient's experience.Reported event: an event regarding revision involving a trident liner 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.The reason for revision was not reported.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, 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 devices and/or additional information become available to indicate further evaluation is warranted, this record will be reopened.
Event or Problem Description
Revision surgery.
Additional Manufacturer Narrative
Reported event: an event regarding crack/fracture 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 fracture of the exeter stem.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, 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 devices and/or additional information become available to indicate further evaluation is warranted, this record will be reopened.
Event or Problem Description
Revision surgery.Update: the patient was revised due to an exeter v40 fracture.

• 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: marisol santiago ; 325 corporate drive; mahwah, NJ 07430 ; 2018315000
• MDR Report Key: 17498704
• Report Number: 0002249697-2023-00887
• Device Sequence Number: 16727532
• Product Code: LPH
• UDI-Device Identifier: 04546540153234
• UDI-Public: 04546540153234
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• PMA/510(K) Number: K121308
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2017
• Device Explanted Year: 2021
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 11/28/2024

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 Expiration Date: 08/21/2021
• Device Catalogue Number: 0580-1-351
• Device Lot Number: G6106164
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 07/13/2023
• Supplement Date Received by Manufacturer: 08/30/2023; 11/05/2024
• Initial Report FDA Received Date: 08/10/2023
• Supplement Report FDA Received Date: 09/24/2023; 11/28/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 08/25/2016
• 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 Sex: Unknown