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

Catalog Number 6942-6-060

Device Problem Fitting Problem (2183)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 10/29/2015

Event Type  malfunction  

Manufacturer Narrative

Additional information has been requested and if received, will be provided in the supplemental report upon completion of the investigation.

Event Description

Accolade c unitrax sleeve did not cold weld on the trunnion and was spinning and could not get sleeve off of head.

Manufacturer Narrative

An event regarding sit/fite issue involving a unitrax sleeve was reported.The event was not confirmed.Method & results: device evaluation and results: the sleeve and the head were returned assembled together and cannot be disassembled.The portion of the sleeve that is visible within the head is visually unremarkable.No further analysis of the devices was possible as they cannot be disassembled.Medical records received and evaluation: a review by a clinical consultant concluded that it is not possible to establish a root cause of failure due to lack of adequate information.Device history review: the reported device was manufactured into final stock with no reported discrepancies.Complaint history review: there have been no other events for the reported lot.Conclusions: the exact cause of the event could not be determined based on the information available.The sleeve and the head were returned assembled together and cannot be disassembled.The portion of the sleeve that is visible within the head is visually unremarkable.A review by a clinical consultant concluded that it is not possible to establish a root cause of failure due to lack of adequate information.No further investigation for this event is possible at this time.

Event Description

Accolade c unitrax sleeve did not cold weld on the trunnion and was spinning and could not get sleeve off of head.

• Brand Name: UNITRAX V40 SLEEVE -4MM
• Type of Device: HIP JOINT FEMORAL (HEMI-HIP) METALLIC CEMENTED OR UNCEMENTED PROSTHESIS.
• Manufacturer (Section D): STRYKER ORTHOPAEDICS-MAHWAH; 325 corporate drive; mahwah NJ 07430
• Manufacturer (Section G): STRYKER ORTHOPAEDICS-CORK; ida industrial estate; carrigtwohill NA
• Manufacturer Contact: beverly lima ; 325 corporate drive; mahwah, NJ 07430 ; 2018315000
• MDR Report Key: 5235369
• MDR Text Key: 31830195
• Report Number: 0002249697-2015-03904
• Device Sequence Number: 1
• Product Code: KWL
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K954077
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,other
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 10/29/2015

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
• Device Operator: Health Professional
• Device Expiration Date: 09/30/2019
• Device Catalogue Number: 6942-6-060
• Device Lot Number: 50423301
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/30/2015
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 10/29/2015
• Initial Date FDA Received: 11/19/2015
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 02/12/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/29/2014
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 81 YR