MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH UNIVERSAL IMPACTOR/POSTIONER; PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/CERAMIC/POLYMER, CEMENTED OR NON-POROUS

Catalog Number 2101-0200

Device Problems Connection Problem (2900); Material Protrusion/Extrusion (2979); Insufficient Information (3190)

Patient Problems Injury (2348); No Known Impact Or Consequence To Patient (2692)

Event Date 12/04/2015

Event Type  malfunction  

Manufacturer Narrative

An evaluation of the device cannot be performed as the device was not returned to the manufacturer.Additional information has been requested and if received, will be provided in the supplemental report.Not returned to manufacturer.

Event Description

During a hip replacement using the trident shell impactor.It was noticed the implant was not being held correctly on the impactor handle and could not be impacted.The shell was attached to the impactor handle and it was noted the threads of the impactor handle extended beyond the implant surface and made in unusable.A second handle was obtained and it was noted that it too had the same extended amount of threads protruding from the handle and thus did not hold the implant correctly.The surgeon was applying significant twisting force when attaching shell to handle.A mallet was used to hit the threaded section of the handle and the screw thread length where the implant attaches was decreased, which enabled the successful fixation of the implant to the handle and then implantation.Both handles were the newer design than the original, which has a removable strike plate on the impaction end of the handle.

Manufacturer Narrative

An event regarding excessive thread length involving a universal impactor/postioner was reported.The event was not confirmed.Method and results: device evaluation could not be performed as the subject device was not returned.Medical records received and evaluation: no medical records were received for review with a clinical consultant.Device history review indicated the devices accepted into final stock from the reported lot were free from discrepancies.Complaint history review: confirmed no other similar events for the reported lot.Conclusions: the investigation determined that the reported failure has been previously investigated under pr.Nc pr was opened to further investigate the observed non-conformance.

Event Description

During a hip replacement using the trident shell impactor.It was noticed the implant was not being held correctly on the impactor handle and could not be impacted.The shell was attached to the impactor handle and it was noted the threads of the impactor handle extended beyond the implant surface and made in unusable.A second handle was obtained and it was noted that it too had the same extended amount of threads protruding from the handle and thus did not hold the implant correctly.The surgeon was applying significant twisting force when attaching shell to handle.A mallet was used to hit the threaded section of the handle and the screw thread length where the implant attaches was decreased, which enabled the successful fixation of the implant to the handle and then implantation.Both handles were the newer design than the original, which has a removable strike plate on the impaction end of the handle.

• Brand Name: UNIVERSAL IMPACTOR/POSTIONER
• Type of Device: PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/CERAMIC/POLYMER, CEMENTED OR NON-POROUS
• Manufacturer (Section D): STRYKER ORTHOPAEDICS-MAHWAH; 325 corporate drive; mahwah NJ 07430
• Manufacturer (Section G): STRYKER ORTHOPAEDICS-MAHWAH; 325 corporate drive; mahwah NJ 07430
• Manufacturer Contact: beverly lima ; 325 corporate drive; mahwah, NJ 07430 ; 2018315000
• MDR Report Key: 5316243
• MDR Text Key: 34759816
• Report Number: 0002249697-2015-04411
• Device Sequence Number: 1
• Product Code: MAY
• Combination Product (y/n): N
• Reporter Country Code: AU
• PMA/PMN Number: K123604
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,other
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 12/04/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/21/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 02/28/2019
• Device Catalogue Number: 2101-0200
• Device Lot Number: SMM9A09
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 01/21/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 02/18/2014
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 66 YR