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

Catalog Number	6942-7-075
Medical Device Problem Code	Mechanical Problem (1384)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	09/09/2019
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.If additional information is received, it will be provided in a supplemental report upon completion of the investigation.
Event or Problem 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.
Additional 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 or Problem 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
• Common Device Name: PROSTHESIS, HIP, HEMI-, FEMORAL, METAL
• Manufacturer (Section D): STRYKER ORTHOPAEDICS-MAHWAH; 325 corporate drive; mahwah NJ 07430
• MDR Report Key: 9155933
• Report Number: 0002249697-2019-03390
• Device Sequence Number: 2449339
• Product Code: KWL
• UDI-Device Identifier: 07613327013474
• UDI-Public: 07613327013474
• Combination Product (Y/N): N
• Initial Reporter State: WI
• Initial Reporter Country: US
• PMA/510(K) Number: K992570
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 01/09/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this a Product Problem Report?: Yes
• Operator of Device: 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
• Initial Date Received by Manufacturer: 09/09/2019
• Supplement Date Received by Manufacturer: 12/10/2019
• Initial Report FDA Received Date: 10/04/2019
• Supplement Report FDA Received Date: 01/09/2020
• 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: 81 YR
• Patient Weight: 69