MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH UNITRAX V40 SLEEVE +0MM (STD); PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, CEMENTED

Catalog Number	6942-6-065
Medical Device Problem Code	Degraded (1153)
Health Effect - Clinical Code	Injury (2348)
Date of Event	02/18/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
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
Trunionosis between 35.5 exeter stem trunion 0580-351and unitrax sleeve 6942-6-065.
Additional Manufacturer Narrative
Event regarding corrosion involving an an unitrax v40 sleeve was reported.The event was not confirmed.Method & results: -product evaluation and results: no product was returned for evaluation however photographs were provided for review.The photograph shows a recently explanted head with the sleeve inside.It is unknown if the head is a stryker device.The photograph shows the device with blood and black liquid/substance visible on it.-clinician review: not performed as the clinical consultant stated the following comment: need operative reports, office/clinical reports, serial x-rays, etc.-product history review: not performed as no lot information was provided.-complaint history review: not performed as no lot information was provided conclusion: the event itself could not be confirmed and exact cause of the event could not be determined because insufficient information was provided.Further information such as device lot information and return, serial x-rays, office/clinical reports, operative reports, histopathology reports as well as patient history and follow up notes are required to complete the investigation for determining a root cause.No further investigation is required at this time.If additional information becomes available to indicate further evaluation is warranted, this record will be reopened.
Event or Problem Description
Trunionosis between 35.5 exeter stem trunion 0580-351and unitrax sleeve 6942-6-065 event update per sales rep's response: ".Patient presented for revision of unitrax due to progression of symptoms.Upon opening the capsule dr mentioned an increase of fluid and after removing the head/sleeve from the trunion a black liquid was identified between the prosthesis and around the head neck junction.Dr then implanted a new exeter stem and converted to a tha.

• Brand Name: UNITRAX V40 SLEEVE +0MM (STD)
• 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: 8429106
• Report Number: 0002249697-2019-01360
• Device Sequence Number: 10818492
• Product Code: JDI
• UDI-Device Identifier: 07613327013412
• UDI-Public: 07613327013412
• 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 Explanted Year: 2019
• Reporter Type: Manufacturer
• Report Source: health professional,other
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 05/06/2019

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 Catalogue Number: 6942-6-065
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 02/18/2019
• Supplement Date Received by Manufacturer: 04/08/2019
• Initial Report FDA Received Date: 03/18/2019
• Supplement Report FDA Received Date: 05/06/2019
• 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: 49 YR
• Patient Weight: 67