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

Model Number	0580-1-371
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Fall (1848); Bone Fracture(s) (1870)
Date of Event	12/18/2022
Type of Reportable Event	Serious Injury
Event or Problem Description
Patient admitted to hospital following a fall resulting in periprosthetic fracture.Revision surgery resulting in replacement prostheses being implanted.
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 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.
Event or Problem Description
Patient admitted to hospital following a fall resulting in periprosthetic fracture.Revision surgery resulting in replacement prostheses being implanted.
Additional Manufacturer Narrative
Reported event: an event regarding periprosthetic fracture involving an exeter stem was reported.The event was confirmed via evaluation of the provided medical records.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: a review of the provided medical records by a clinical consultant stated the following comment: i have had the opportunity to review documentation related to pi including the product inquiry summary, and a post-operative ap pelvis x-ray/ the event description from the product inquiry summary states: patient admitted to hospital following a fall resulting in periprosthetic fracture.Revision surgery resulting in replacement prostheses being implanted.A post-operative x-ray demonstrates a cemented femoral stem along with an extended trochanteric plate.The post-operative x-ray with extended trochanteric plate is consistent with treatment of a peri-prosthetic fracture.The root cause of this fracture being a fall cannot be confirmed.Should additional information become available i would be happy to further this assessment.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: no further investigation for this event is possible at this time.If additional information become available to indicate further evaluation is warranted, this record will be reopened.

• 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: diana rogers ; 210 centennial avenue; centennial park, elstree; borehamwood WD6 3-SJ ; UK WD6 3SJ ; 2082386500
• MDR Report Key: 16127097
• Report Number: 0002249697-2023-00025
• Device Sequence Number: 7673630
• Product Code: LPH
• UDI-Device Identifier: 04546540153258
• UDI-Public: 04546540153258
• 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 Explanted Year: 2022
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 04/05/2023

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: 03/31/2012
• Device Model Number: 0580-1-371
• Device Catalogue Number: 0580-1-371
• Device Lot Number: G1771894
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 12/18/2022
• Supplement Date Received by Manufacturer: 03/13/2023
• Initial Report FDA Received Date: 01/09/2023
• Supplement Report FDA Received Date: 04/05/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 03/01/2007
• 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: 88 YR
• Patient Sex: Female