MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH UNITRAX MODULAR ENDO HEAD 47MM; PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, CEMENTED

Catalog Number	6942-5-047
Medical Device Problem Code	Migration (4003)
Health Effect - Clinical Code	Injury (2348)
Date of Event	08/01/2018
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 events for the lot referenced.It was noted that the device is not available for evaluation.If additional information is received, it will be provided in a supplemental report upon completion of the investigation.Device not returned.
Event or Problem Description
It was reported that patient's left hip was revised due to the migration of the unipolar head from the acetabulum into the pelvis.Patient was revised to a total hip including a trident shell, adm/mdm liner construct, and a femoral head.Stem was well fixed, well positioned, and was not revised.
Event or Problem Description
It was reported that patient's left hip was revised due to the migration of the unipolar head from the acetabulum into the pelvis.Patient was revised to a total hip including a trident shell, adm/mdm liner construct, and a femoral head.Stem was well fixed, well positioned, and was not revised.
Additional Manufacturer Narrative
An event regarding periprosthetic fracture involving a metal head was reported.The event was confirmed by clinical consultant after review of x-ray provided.-product evaluation and results: not performed as the device was not returned.A review of the provided medical records and x-rays by a clinical consultant indicated: x-ray confirms protusio of the hip, need operative reports, need patient clinical notes, no confirmation of post op revision treatments, need serial x-rays and examination of the explanted components.A review of the device manufacturing records indicate that all devices accepted into final stock were free from discrepancies.There were no other events for the lot provided.The medical review confirms the event but the exact cause of the event could not be determined because insufficient information was provided.Further information such as operative reports, patient clinical notes, confirmation of post op revision treatments, serial x-rays and examination of the explanted components 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.

• Brand Name: UNITRAX MODULAR ENDO HEAD 47MM
• 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: 7826356
• Report Number: 0002249697-2018-02704
• Device Sequence Number: 2447410
• Product Code: JDI
• UDI-Device Identifier: 07613327032420
• UDI-Public: 07613327032420
• Combination Product (Y/N): N
• Initial Reporter State: MA
• Initial Reporter Country: US
• PMA/510(K) Number: K173499
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2008
• 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): 11/01/2018

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: 12/31/2012
• Device Catalogue Number: 6942-5-047
• Device Lot Number: A07V266
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 08/01/2018
• Supplement Date Received by Manufacturer: 10/04/2018
• Initial Report FDA Received Date: 08/29/2018
• Supplement Report FDA Received Date: 11/01/2018
• 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: 72 YR