MAUDE Adverse Event Report: STRYKER GMBH LATERAL ASSEMBLY, RADIAL STEM IMPLANT, SIZE 3; PROSTHESIS, ELBOW, SEMICONSTRAINED, CEMENTED

Catalog Number 3100002

Device Problem Detachment of Device or Device Component (2907)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 08/22/2017

Event Type  Injury  

Manufacturer Narrative

Once the investigation has been completed any additional information will be reported in a supplemental report.

Event Description

As reported by rep: "xrays post op show the radial head disengaged from the stem." after removal of the head and stem the surgical tech attempted to reengage the two components, but was able to easily separate them without pressing the "disengage button" on the side of the implant.

Manufacturer Narrative

The reported event that lateral assembly, radial head impl assembly,size3 was alleged of 'poor fixation' could not be confirmed, since the returned device is conforming to specifications and is fully functional.Based on investigation, the root cause was attributed to be user related.The failure was caused by possible inadequate disengaging of the radial head impl assembly.The device inspection revealed the following: the returned lateral assembly, radial head impl assembly,size3 was tested using a rhead lateral assembly tool.Several attempts of locking and unlocking of the radial head impl assembly did not show any problems at all.Both items could be engaged and disengaged accordingly.The assembly is fully functional and could be locked securely (could not be taken apart without the assembly tool).See attachments for details: a review of the device history for the reported lot did not indicate any abnormalities.No corrective actions are required at this time.A review of the labeling did not indicate any abnormalities.No indications of material, manufacturing or design related problems were found during the investigation.If the device is returned or if any additional information is provided, the investigation will be reassessed.Extracts from labeling: the operative technique ((b)(4)) was reviewed: ''the head and stem components are coupled together using the rhead lateral assembly tool.Prior to beginning assembly, all soft tissue must be cleared away from the locking mechanism.Position the appropriately sized radial head implant so that the male portion of the head locking mechanism is engaged by the female portion of the stem locking mechanism (fig.10).Place the rhead lateral assembly tool around the grooved collar of the stem and ensure the dimple on the radial head implant is engaged by the pin on the advancer of the rhead lateral assembly tool (fig.11a).The trigger on the rhead lateral assembly tool is then compressed to advance the radial head implant until it is fully engaged by the stem.The head is fully locked to the stem when an audible snap is heard or felt.Visually, the head should be concentric with the stem when properly engaged (fig.11b).The assembly tool can now be removed.If disassembly should be needed, rotate the forearm and reverse the rhead lateral assembly tool until the pin on the advancer is aligned with the dimple on the opposite side of the radial head implant (fig.12b).Compress the trigger on the rhead lateral assembly tool until the radial head implant disengages from the stem (fig.12a).Note that the radial head implant is intended for one time use.The radial head implant may not be reused once it is disengaged from the stem.A new radial head implant must be used if the original head is disengaged for any reason.Note:in the elbow management solutions tray, the head and stem trial components (not pictured) are designed to be a non-locking lateral assembly mechanism.These components will be utilized as explained on page 7.In the rhead combination tray, the head and stem components (not pictured) are a morse taper design and should be utilized as explained on page 7.Note: care should be taken to protect the articulating surfaces between the head and stem of any damage.Including, but not limited to, scratches and contact with bone cement.'' [original statement(s)].The instruction for use (v15130_rev aa_) rhead system and uni-elbow system ifu) was reviewed: ''surgical procedures an operative technique is available describing detailed surgical procedure for use of these implant devices.It is the responsibility of the surgeon to be familiar with the procedure before use of these products.In addition, it is the responsibility of the surgeon to be familiar with relevant publications and consult with experienced associates regarding the procedure before use.''.

Event Description

As reported by rep: "xrays post op show the radial head disengaged from the stem." after removal of the head and stem the surgical tech attempted to reengage the two components, but was able to easily separate them without pressing the "disengage button" on the side of the implant.

• Brand Name: LATERAL ASSEMBLY, RADIAL STEM IMPLANT, SIZE 3
• Type of Device: PROSTHESIS, ELBOW, SEMICONSTRAINED, CEMENTED
• Manufacturer (Section D): STRYKER GMBH; bohnackerweg 1; postfach; selzach 2545 ; CH 2545
• Manufacturer (Section G): STRYKER GMBH; bohnackerweg 1; postfach; selzach 2545 ; CH 2545
• Manufacturer Contact: anna jusinski ; 325 corporate drive; mahwah, NJ 07430 ; 2018315000
• MDR Report Key: 6874856
• MDR Text Key: 86558613
• Report Number: 0008031020-2017-00533
• Device Sequence Number: 1
• Product Code: JDB
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 12/01/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/18/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 11/30/2020
• Device Catalogue Number: 3100002
• Device Lot Number: 24982801
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/30/2017
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/13/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 12/31/2015
• 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): Required Intervention
• Patient Age: 53 YR
• Patient Weight: 110