MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH EXETER V40 STEM 50MM NO 1; PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, CEMENTED

Model Number	0580-1-501
Medical Device Problem Code	Insufficient Device Problem Information (3190)
Health Effect - Clinical Codes	Bone Fracture(s) (1870); Injury (2348)
Date of Event	05/24/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Review of the device history records indicate that devices were manufactured and accepted into final stock with no reported discrepancies.There have been no other events for the lot referenced.Device not returned.
Event or Problem Description
Right femoral periprosthetic fracture.Noticed after surgeon review of x-ray after pt fell over.
Additional Manufacturer Narrative
Reported event: an event regarding periprosthetic fracture involving exeter stem was reported.The event was confirmed based on medical review.Method & results: -device evaluation and results: not performed as product was not returned -clinician review: a review of the provided medical records and x-rays was rejected by a clinical consultant indicating: no clinical or pmh, no operative reports, no dated serial x-rays, no description of the event causing the periprosthetic fracture.In this case of reduction and fixation of a periprosthetic femoral fracture without revision of the tha components, there is no evidence that the prosthetic components were involved in the clinical event.Insufficient data is presented to create a medical report for this case.-device history review: all 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 reported lot.Conclusion: it was reported that the patient had right femoral periprosthetic fracture.A review of the provided medical records and x-rays was rejected by a clinical consultant indicating: no clinical or pmh, no operative reports, no dated serial x-rays, no description of the event causing the periprosthetic fracture.In this case of reduction and fixation of a periprosthetic femoral fracture without revision of the tha components, there is no evidence that the prosthetic components were involved in the clinical event.Insufficient data is presented to create a medical report for this case.The event was confirmed.The exact cause of the event could not be determined because insufficient information was provided.Additional information including operative reports, progress notes, x-rays and return of the device are needed to fully investigate the event.If further information becomes available or the product is returned, this investigation will be re-opened.H3 other text : device not returned.
Event or Problem Description
Right femoral periprosthetic fracture.Noticed after surgeon review of x ray after pt fell over.

• Brand Name: EXETER V40 STEM 50MM NO 1
• Common Device Name: PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, CEMENTED
• Manufacturer (Section D): STRYKER ORTHOPAEDICS-MAHWAH; 325 corporate drive; mahwah NJ 07430
• MDR Report Key: 10157599
• Report Number: 0002249697-2020-01197
• Device Sequence Number: 19561129
• Product Code: JDI
• UDI-Device Identifier: 04546540153364
• UDI-Public: 04546540153364
• Combination Product (Y/N): N
• Initial Reporter Country: AU
• PMA/510(K) Number: K173499
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2020
• Reporter Type: Manufacturer
• Report Source: health professional,other
• Initial Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date (Section B): 09/23/2020

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: No Information
• Device Expiration Date: 11/30/2023
• Device Model Number: 0580-1-501
• Device Catalogue Number: 0580-1-501
• Device Lot Number: G7741565
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 05/24/2020
• Supplement Date Received by Manufacturer: 08/28/2020
• Initial Report FDA Received Date: 06/16/2020
• Supplement Report FDA Received Date: 09/23/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention
• Patient Age: 79 YR