MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH EXETER V40 STEM 37.5MM NO 0; PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, CEMENTED

Catalog Number	0580-1-352
Medical Device Problem Codes	Break (1069); Fracture (1260)
Health Effect - Clinical Codes	Injury (2348); Ambulation or Postural Difficulties (2544)
Date of Event	10/24/2019
Type of Reportable Event	Serious Injury
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.
Event or Problem Description
Broken exter stem.Revised stem to a cement.In cement stem.
Additional Manufacturer Narrative
An event regarding crack/fracture involving an exeter stem was reported.The event was confirmed by clinician review of the provided x-ray and review of the provided images of the device.Method & results: -device evaluation and results: the reported device was not returned however photographs were provided for review.The photographs shows and intraoperative image with the device in situ and also a photo of the recently explanted exeter stem and ceramic head covered in tissue and blood.The stem is clearly fractured at the neck of the device.-clinician review: a review of the provided medical records by a clinical consultant stated the following comment: x-rays provided confirm fracture on stem, need additional information; primary and revision operative reports, clinical and past medical history, additional serial dated x-rays and examination of explanted components.-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: the exact cause of the event could not be determined because insufficient information was provided.Additional information including primary and revision operative reports, clinical and past medical history, additional serial dated x-rays and examination of explanted components are needed to fully investigate the event.If further information becomes available or the product is returned, this investigation will be re-opened.
Event or Problem Description
Broken exter stem.Revised stem to a cement in cement stem.

• Brand Name: EXETER V40 STEM 37.5MM NO 0
• 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: 9353392
• Report Number: 0002249697-2019-03835
• Device Sequence Number: 2207837
• Product Code: JDI
• UDI-Device Identifier: 04546540153241
• UDI-Public: 04546540153241
• 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: 2016
• Device Explanted Year: 2019
• Reporter Type: Manufacturer
• Report Source: company representative,other
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 01/14/2020

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: Health Professional
• Device Expiration Date: 07/31/2020
• Device Catalogue Number: 0580-1-352
• Device Lot Number: G5717456
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 10/24/2019
• Supplement Date Received by Manufacturer: 12/16/2019
• Initial Report FDA Received Date: 11/21/2019
• Supplement Report FDA Received Date: 01/14/2020
• 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: 69 YR