MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH UNITRAX C-TAPER SLEEVE +0MM; PROSTHESIS, HIP, HEMI-, FEMORAL, METAL

Catalog Number 6942-7-065

Device Problems Fitting Problem (2183); Misassembly by Users (3133)

Patient Problems No Consequences Or Impact To Patient (2199); No Known Impact Or Consequence To Patient (2692)

Event Date 11/14/2015

Event Type  malfunction  

Manufacturer Narrative

A supplemental report will be submitted upon completion of the investigation.

Event Description

During a hemi with dr.(b)(6), the circulator handed the implants over to the tech and she went ahead and assembled the unipolar construct (the below c-taper neck adjustment sleeve and 51mm unipolar head) with the letters of the sleeve facing up towards the ceiling.Dr.(b)(6).Impacted said construct onto the trunnion of his already cemented omnifit hfx c-taper stem.When he went to pull on the head, the whole construct came off.I went ahead and had the tech disassemble the sleeve from the head and suggested dr.(b)(6).Impact the sleeve onto the trunnion separate of the head.He took my advice and the head and sleeve came off once again.I went ahead and opened another set of implants (51mm unipolar head / +0 c-taper neck adjustment sleeve).He dropped the sleeve into the head, like we did initially, and impacted the construct on the trunnion.When he went to pull on the second implant set i had given him, the entire construct was well fixed on the trunnion and he started closing.

Manufacturer Narrative

An event regarding assembly issues involving a unitrax sleeve and unitrax head was reported.The event was not confirmed.Device evaluation and results: not performed as the device has not been received.A capa has been opened to address this issue.Medical records received and evaluation: insufficient information was received for review with a clinical consultant.Device history review: a review of the device history records indicate the devices were manufactured and accepted into final stock with no reported discrepancies.Complaint history review: there have been no other similar events for the lot referenced.Conclusions: the exact cause of the event could not be determined based on the information provided.During an index surgery, the surgeon stated that the unitrax sleeve did not fit with the trunnion of the omnifit stem or it was an issue with the head.The stem was left implanted and a new head and sleeve successfully implanted.A device evaluation not be performed as the device has not been received.A capa has been opened to address this issue.A review of the surgical protocol noted that after stem implantation, the modular adaptor sleeve is impacted onto the implanted stem with two or three mallet blows.The unitrax head component is then impacted onto the adaptor with two or three mallet blows.No further investigation for this event is possible at this time as insufficient information was received by stryker orthopaedics.If additional information become available, this investigation will be reopened.Product surveillance will continue to monitor for trends.

Event Description

During a hemi with dr.(b)(6) the circulator handed the implants over to the tech and she went ahead and assembled the unipolar construct (the below c-taper neck adjustment sleeve and 51mm unipolar head) with the letters of the sleeve facing up towards the ceiling.Dr.(b)(6) impacted said construct onto the trunnion of his already cemented omnifit hfx c-taper stem.When he went to pull on the head, the whole construct came off.I went ahead and had the tech disassemble the sleeve from the head and suggested dr.(b)(6) impact the sleeve onto the trunnion separate of the head.He took my advice and the head and sleeve came off once again.I went ahead and opened another set of implants (51mm unipolar head / +0 c-taper neck adjustment sleeve).He dropped the sleeve into the head, like we did initially, and impacted the construct on the trunnion.When he went to pull on the second implant set i had given him, the entire construct was well fixed on the trunnion and he started closing.

• Brand Name: UNITRAX C-TAPER SLEEVE +0MM
• Type of Device: PROSTHESIS, HIP, HEMI-, FEMORAL, METAL
• 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: timothy rice ; 325 corporate drive; mahwah, NJ 07430 ; 2018315000
• MDR Report Key: 5278588
• MDR Text Key: 33728804
• Report Number: 0002249697-2015-04189
• Device Sequence Number: 1
• Product Code: KWL
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K992570
• 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: 09/29/2017

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: 11/17/2019
• Device Catalogue Number: 6942-7-065
• Device Lot Number: 50061301
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 11/14/2015
• Initial Date FDA Received: 12/09/2015
• Supplement Dates Manufacturer Received: 08/31/2017
• Supplement Dates FDA Received: 09/29/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 11/17/2014
• 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: 88 YR