MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH 26MM STD LFIT V40 HEAD

Catalog Number	6260-9-126
Medical Device Problem Code	Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	Injury (2348)
Date of Event	11/09/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
A review of the device history records indicates that the reported devices were manufactured and accepted into final stock with no reported discrepancies.The complaint history review indicated that there were no similar events for the reported lot.If additional information is received, it will be provided in a supplemental report upon completion of the investigation.Not available.
Event or Problem Description
It was reported through the submission of a revision implant sheet that patient's left hip was revised.
Event or Problem Description
It was reported through the submission of a revision implant sheet that patient's left hip was revised.
Additional Manufacturer Narrative
Corrected manufacturer of the device.An event regarding revision surgery involving a metal head was reported.The event was not confirmed.Method & results: device evaluation and results: not performed as the reported device was not returned for evaluation.Medical records received and evaluation: no medical records were received for review with a clinical consultant.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.Conclusions: the exact cause of the event could not be determined because further information such as return of device, pre- and post-operative x-rays and the primary 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 as no devices and insufficient information were received by stryker orthopaedics.If devices and / or additional information become available to indicate further evaluation is warranted, this record will be reopened.

• Brand Name: 26MM STD LFIT V40 HEAD
• Common Device Name: 26MM STD LFIT V40 HEAD
• Manufacturer (Section D): STRYKER ORTHOPAEDICS-MAHWAH; 325 corporate drive; mahwah NJ 07430
• MDR Report Key: 8142319
• Report Number: 0002249697-2018-03941
• Device Sequence Number: 10811807
• Product Code: JDI
• UDI-Device Identifier: 07613327013030
• UDI-Public: 07613327013030
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: K173499
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2018
• Device Explanted Year: 2018
• Reporter Type: Manufacturer
• Report Source: health professional,other
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 01/03/2019

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: 02/28/2023
• Device Catalogue Number: 6260-9-126
• Device Lot Number: 63116708
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 11/09/2018
• Supplement Date Received by Manufacturer: 12/05/2018
• Initial Report FDA Received Date: 12/07/2018
• Supplement Report FDA Received Date: 01/03/2019
• 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: 88 YR