MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH UNITRAX C-TAPER SLEEVE +5MM; PROSTHESIS, HIP, HEMI-, FEMORAL, METAL

Catalog Number 6942-7-075

Device Problem Mechanical Problem (1384)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 09/09/2019

Event Type  malfunction  

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.If additional information is received, it will be provided in a supplemental report upon completion of the investigation.

Event Description

Occurred in or during hemiarthroplasty.During final implantation, the c-taper neck sleeve would not lock onto the c- taper stem.With minimal pressure the +5 c-taper neck sleeve would slide off the trunnion of the implanted stem.The sleeve fit and secured to the unitrax head properly, but when put onto the trunnion, it would easily slide off.This caused about a 10 minute delay to try and problem solve, and ultimately needed to open a different sleeve.We had to open a +10 sleeve and that worked properly.Update (b)(6) 2019: spoke to rep.Rep was present in the o.R.At the time of event.The implant label was not applied to the usage sheet.No further information will be available.

Manufacturer Narrative

An event regarding assembly issue involving a unipolar sleeve was reported.The event was not confirmed.Method & results: -product evaluation and results: visual inspection: as per attached product return images there is no visual damage can be observed on device.Dimensional inspection was performed and no discrepancies were found.Functional inspection - an attempt was made to implant the reported device.The device is not designed to be implanted more than once.Therefore, a functional test would not be an accurate reflection of its original manufactured condition.Ma- material analysis was not performed as this event is not related to material integrity.Clinician review: not performed as no information was provided for review.Product history review: review of the product history records indicate all devices were manufactured and accepted into final stock with no reported relevant discrepancies.Complaint history review: lot id: there have been no other events for the lot referenced.Conclusion: it was reported that c-taper neck sleeve would not lock onto the c- taper stem.As per attached product return images there is no visual damage can be observed on device.Dimensional inspection was performed and no discrepancies were found.Functional inspection - an attempt was made to implant the reported device.The device is not designed to be implanted more than once.Therefore, a functional test would not be an accurate reflection of its original manufactured condition.Ma- material analysis was not performed as this event is not related to material integrity.The exact cause of the event could not be determined because insufficient information was provided.Additional information including operative reports are needed to fully investigate the event.If further information becomes available, this investigation will be re- opened.

Event Description

Occurred in or during hemiarthroplasty.During final implantation, the c-taper neck sleeve would not lock onto the c- taper stem.With minimal pressure the +5 c-taper neck sleeve would slide off the trunnion of the implanted stem.The sleeve fit and secured to the unitrax head properly, but when put onto the trunnion, it would easily slide off.This caused about a 10 minute delay to try and problem solve, and ultimately needed to open a different sleeve.We had to open a +10 sleeve and that worked properly.Update 10/september/2019 wg: spoke to rep.Rep was present in the operating room.At the time of event.The implant label was not applied to the usage sheet.No further information will be available.

• Brand Name: UNITRAX C-TAPER SLEEVE +5MM
• Type of Device: PROSTHESIS, HIP, HEMI-, FEMORAL, METAL
• Manufacturer (Section D): STRYKER ORTHOPAEDICS-MAHWAH; 325 corporate drive; mahwah NJ 07430
• MDR Report Key: 9155933
• MDR Text Key: 166002952
• Report Number: 0002249697-2019-03390
• Device Sequence Number: 1
• Product Code: KWL
• UDI-Device Identifier: 07613327013474
• UDI-Public: 07613327013474
• Combination Product (y/n): N
• PMA/PMN Number: K992570
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Type of Report: Initial,Followup
• Report Date: 01/09/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/04/2019
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 08/31/2023
• Device Catalogue Number: 6942-7-075
• Device Lot Number: 67077403
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/13/2019
• Date Manufacturer Received: 12/10/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 81 YR
• Patient Weight: 69