MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH UNKNOWN MDM COCR LINER; HIP IMPLANT

Catalog Number UNK_SHC

Device Problem Difficult To Position (1467)

Patient Problem No Patient Involvement (2645)

Event Date 01/10/2017

Event Type  malfunction  

Manufacturer Narrative

It was noted that the device is not available for evaluation.Additional information has been requested.Should additional information become available, it will be provided in a supplemental report upon completion of the investigation.

Event Description

Review of the post market surveillance survey noted that the surgeon is not satisfied with question 4, "the shell allows for easy assembly and impaction of the mdm cocr liner." and question 5, "existing instruments allow for various surgical approaches and techniques." surgeon also commented regarding question 4, "i suffer from seating", and question 6, "i have to hit repeatedly, because it is too difficult to set mdm liner.".

Manufacturer Narrative

Review of the post market surveillance survey noted that the surgeon is not satisfied with question 4, "the shell allows for easy assembly and impaction of the mdm cocr liner." surgeon also commented regarding question 9 that "the letters written down at package is too little.So i can't read those." the surgeon gave a 4 out of 5 overall satisfaction rating for the adm system.This event relates to surgeon feedback and based on the information provided does not reflect an issue regarding the device locking mechanism itself.A review of strykers mdm x3 modular dual mobility acetabular system surgical technique, mdm-sp-2., notes the following regarding seating verification: "step 7 liner implantation: 1.Ensure that the inside of the shell is clean, dry and free of soft tissue or any other debris, which could prevent the liner from properly seating in the shell.2.Gently introduce the mdm liner making sure that the liner flange scallops are aligned with the removal tool slots at the rim of the shell.This orientation will allow the liner to rest on the four indexing barbs and will ensure that the liner is parallel with the shell.Next, slowly turn the liner until it drops into the final pre-locking position.Correct rotational orientation will result in the liner tabs aligned with the removal tool slots.Apply finger pressure around the rim of the liner first to engage the liner within the shell.It may then be necessary to lightly tap on the rim of the liner with the final cup impactor handle (2101-0130 ¿ ), working around the rim in all four quadrants, to ensure the liner is properly seated in the shell.The liner is properly seated when there is no further rocking or movement of the liner within the shell.This step should be done prior to final impaction of the liner.3.Select the ball impactor tip (1235-0-013) and assemble to the final cup impactor handle (2101-0130).The final cup impactor handle comes pre-assembled with a blunt tip.Please unscrew the tip in order to assemble the ball impactor tip.Ensure the ball impactor tip is threaded tightly onto the impactor handle.Strike the handle with approximately four mallet blows to fully seat the liner using the slotted mallet (1120-1000).4.Verify liner is properly aligned and fully seated into the acetabular shell.Check the taper lock by running a small blunt instrument (or the liner removal tool, 2112-0000) around the periphery of the shell/ liner interface.There should not be any space between the rim of the shell and the under side of the liner rim.5.Visually assess the inner articular surface of the mdm liner to ensure it is not scratched or damaged prior to the trial insert/head reduction." no further investigation is required at this time.If additional information becomes available, this investigation will be reopened.

Event Description

Review of the post market surveillance survey noted that the surgeon is not satisfied with question 4, "the shell allows for easy assembly and impaction of the mdm cocr liner." and question 5, "existing instruments allow for various surgical approaches and techniques." surgeon also commented regarding question 4, "i suffer from seating", and question 6, "i have to hit repeatedly, because it is too difficult to set mdm liner.".

• Brand Name: UNKNOWN MDM COCR LINER
• Type of Device: HIP IMPLANT
• 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: keyla colon ; 325 corporate drive; mahwah, NJ 07430 ; 2018315000
• MDR Report Key: 6368370
• MDR Text Key: 69017621
• Report Number: 0002249697-2017-00708
• Device Sequence Number: 1
• Product Code: KWY
• Combination Product (y/n): N
• 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: 04/20/2017

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 Catalogue Number: UNK_SHC
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 01/31/2017
• Initial Date FDA Received: 03/01/2017
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 04/20/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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