MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH UNITRAX V40 SLEEVE +4MM; HIP JOINT FEMORAL (HEMI-HIP) METALLIC CEMENTED OR UNCEMENTED PROSTHESIS

Catalog Number	6942-6-070
Medical Device Problem Code	Device Difficult to Setup or Prepare (1487)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	07/12/2019
Type of Reportable Event	Malfunction
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 similar events for the lot referenced.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
Primary procedure, left hip hemiarthroplasty, direct anterior approach.It was reported that the sleeve was assembled in the unitrax head and brought to the surgeon.When the surgeon turned the construct over to implant it, the sleeve fell out.The sleeve was re-inserted into the head, and the construct was impacted on the stem.The construct would not lock.The construct was brought to the back table and another head/ sleeve construct (same catalog number, different lot number) was used and performed as expected.Surgery was completed successfully with a delay of approximately 5 minutes.Rep confirmed that no further information will be available.
Additional Manufacturer Narrative
N event regarding seating/locking issue involving a unitrax sleeve was reported.Conclusion: based on the provided information it has been determined that this event is associated with an off-label application.The surgical protocol for the untrax unipolar system, lit.No.Lunist 2.5m 07/01, was reviewed and noted the following: step 4: impact modular adaptor sleeve after stem implantation, impact modular adaptor sleeve (v-40,¿ c-taper, or 2-52) onto implanted stem with two or three mallet blows to the unitrax® head sleeve impactor.Step 5: impact unitrax® /reduce femur impact the unitrax® head component onto the adaptor with two or three mallet blows.Based on the event description, it was reported that the sleeve was assembled in the unitrax head and brought to the surgeon.When the surgeon turned the construct over to implant it, the sleeve fell out.The sleeve was re-inserted into the head, and the construct was impacted on the stem.This event is off label as the sleeve should have been impacted onto the stem before it was assembled to the head.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
Primary procedure, left hip hemiarthroplasty, direct anterior approach.It was reported that the sleeve was assembled in the unitrax head and brought to the surgeon.When the surgeon turned the construct over to implant it, the sleeve fell out.The sleeve was re-inserted into the head and the construct was impacted on the stem.The construct would not lock.The construct was brought to the back table and another head/sleeve construct (same catalog number, different lot number) was used and performed as expected.Surgery was completed successfully with a delay of approximately 5 minutes.Rep confirmed that no further information will be available.

• Brand Name: UNITRAX V40 SLEEVE +4MM
• Common Device Name: HIP JOINT FEMORAL (HEMI-HIP) METALLIC CEMENTED OR UNCEMENTED PROSTHESIS
• Manufacturer (Section D): STRYKER ORTHOPAEDICS-MAHWAH; 325 corporate drive; mahwah NJ 07430
• MDR Report Key: 8873366
• Report Number: 0002249697-2019-02770
• Device Sequence Number: 13983204
• Product Code: KWL
• UDI-Device Identifier: 07613327013429
• UDI-Public: 07613327013429
• Combination Product (Y/N): N
• Initial Reporter State: TN
• Initial Reporter Country: US
• PMA/510(K) Number: K954077
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional,other
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 11/11/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 04/30/2024
• Device Catalogue Number: 6942-6-070
• Device Lot Number: 71594902
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 07/12/2019
• Supplement Date Received by Manufacturer: 10/14/2019
• Initial Report FDA Received Date: 08/08/2019
• Supplement Report FDA Received Date: 11/11/2019
• 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: Other
• Patient Age: 76 YR