MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH 26MM -3 LFIT V40 HEAD; PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, CEMENTED

Catalog Number	6260-9-026
Medical Device Problem Code	Unstable (1667)
Health Effect - Clinical Code	Injury (2348)
Date of Event	01/25/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
An event regarding instability involving a metal head was reported.The event was not confirmed.Method & results: product evaluation and results: not performed as the device was not returned.Medical records received and evaluation: no medical information was provided for review by a clinical consultant.Product history review: a review of the device manufacturing records indicate that all devices were manufactured and accepted into final stock with no reported relevant discrepancies.Complaint history review: there were no other events reported for this lot.Conclusions: the exact cause of the event could not be determined because insufficient information was provided.Further information such as 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 was received by stryker orthopaedics.If devices and / or additional information become available to indicate further evaluation is warranted, this record will be reopened.
Event or Problem Description
It was reported that patient's left hip was revised from a hemi to a total hip 4 days post-op due to instability.Possible cause or contributor to instability was not reported to the rep.A 47x26 bipolar component and 26 -3 metal head were revised to a total hip construct with a 54mm shell and screw, adm/mdm liner construct, and biolox ceramic head.

• Brand Name: 26MM -3 LFIT V40 HEAD
• 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: 8361412
• Report Number: 0002249697-2019-01144
• Device Sequence Number: 1833437
• Product Code: JDI
• UDI-Device Identifier: 07613327012989
• UDI-Public: 07613327012989
• 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: 2019
• Device Explanted Year: 2019
• Reporter Type: Manufacturer
• Report Source: health professional,other
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 02/22/2019

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: 10/31/2023
• Device Catalogue Number: 6260-9-026
• Device Lot Number: 67706208
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/25/2019
• Initial Report FDA Received Date: 02/22/2019
• 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