MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH UNITRAX V40 SLEEVE -4MM; PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, CEMENTED

Catalog Number	6942-6-060
Medical Device Problem Code	Unstable (1667)
Health Effect - Clinical Codes	Unspecified Infection (1930); Injury (2348)
Date of Event	07/15/2014
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
An event regarding infection and instability involving a other hip sleeve was reported.The event was not confirmed.Method & results: product evaluation and results: material analysis, visual, functional and dimensional inspections could not be performed as the device was not returned.Medical records received and evaluation: not performed as no medical information was received for review.Product history review: a review of the device manufacturing records indicate that all devices accepted into final stock were free from discrepancies.Complaint history review: there have been no other similar events for the lot referenced.There have been no other similar events for the sterile lot referenced.The following devices were also listed in this report: unitrax modular endo head 43mm; cat# 6942-5-043; lot# mmn01p; size 3 accolade ii 132 deg; cat# 6720-0330 ; lot# 45787903; it cannot be determined which, if any of these devices may have caused or contributed to the patient's experience.Conclusions: the exact cause of the event could not be determined because insufficient information was provided.Further information such as return of the device, pathology reports, 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.If devices and / or additional information become available to indicate further evaluation is warranted, this record will be reopened.Device not available.
Event or Problem Description
Postoperative diagnosis: patient underwent left hip hemi arthroplasty for femoral neck fracture (b)(6) 2014.Patient returned to have revision arthroplasty with insertion of antibiotic beads for hip infection (b)(6) 2014 reported as cors per 1862hip.Patient returned for resection due to instability and infection (b)(6) 2014.All components exchanged.

• Brand Name: UNITRAX V40 SLEEVE -4MM
• 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: 8352358
• Report Number: 0002249697-2019-01097
• Device Sequence Number: 1954838
• Product Code: JDI
• UDI-Device Identifier: 07613327013405
• UDI-Public: 07613327013405
• Combination Product (Y/N): N
• Initial Reporter State: PA
• Initial Reporter Country: US
• PMA/510(K) Number: K173499
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2014
• Device Explanted Year: 2014
• Reporter Type: Manufacturer
• Report Source: health professional,other
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 02/19/2019

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: 01/31/2019
• Device Catalogue Number: 6942-6-060
• Device Lot Number: 46579202
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/23/2019
• Initial Report FDA Received Date: 02/19/2019
• 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 Weight: 68