MAUDE Adverse Event Report: ZIMMER GMBH ANATOMICAL SHOULDER DOMELOCK, DOME, CENTRIC

Model Number N/A

Device Problem Misassembled (1398)

Patient Problem No Code Available (3191)

Event Date 06/28/2018

Event Type  malfunction  

Manufacturer Narrative

(b)(4).The manufacturer did not receive x-rays, or other source documents for review.The manufacturer did not receive the device for investigation.The device history records were reviewed and found to be conforming.Additional information has been requested and is currently not available.A cause for this specific event cannot be ascertained from the information provided.As soon as supplemental information becomes available an updated report will be submitted.(b)(4).

Event Description

During surgery, the as dome centric was jammed.Despite, the surgeon was able to adjust it and the device was successfully implanted.

Event Description

No change to previously reported event.

Manufacturer Narrative

Device history records (dhr): the dhr for the expansion ball has been reviewed and it confirms that a 100%-inspection after turning as well as a 1,0n2q- inspection after milling using the cmm measuring machine has been performed.Moreover a 100% functional test has been performed.The dimensions of the product were confirmed to be within the specifications.The dhr for the dome has been reviewed and it confirms that a 100%-inspection using the cmm measuring machine has been performed.The dimensions of the product were confirmed to be within the specifications.No trend considering the following event is identified: damaged threads.Event summary: it was reported that the ball-taper and the dome were stuck upon assembly, as the surgeon tried to freely move the ball-taper within the dome.Review of received data: no medical data such as surgical notes or any other case-relevant documents received.Devices analysis: no product was returned to zimmer biomet for in-depth analysis, as the implantation could be completed successfully.Review of product documentation: anatomical shoulderdomelock system surgical technique explains in detail how to assembly the domelock dome and ball- taper with the expansion pin: assemble the dome onto the ball-taper over the ring machined around the ball of the ball-taper, so that it is loosely assembled.The surgical technique states that after the correct size and position of the trial head is determined: firmly tap the expansion pin into the assembled trial head construct, using the pin impactor to establish a firm connection between the dome ball- taper.The patient specific orientation of the dome is now pre-locked.Afterwards, remove the pre-locked dome and place it into the assembly block.Using the assembly block, firmly impact the expansion pin into the pre-locked dome using the pin impactor.Continue to impact the expansion pin until the laser mark on the pin impactor is no longer visible above the assembly block.Root cause analysis: root cause determination using rmw: surgeon has a hard time to set the dome to the anatomical correct position.Due to dome sticks on the domelock expansion ball: possible, as it cannot be excluded based on the available information.However, the functional relationship analysis (fra) verifies that, by design, the dome is able to freely move on the expansion ball.The surgical technique describes steps associated with the correct assembly of the domelock expansion ball and the dome and provides additional information to the user but is not considered to further mitigate the risk.Implant breakage due to design specification not met (i.E.Geometrical characteristics).Not possible: the manufacturing records confirm that the design specifications have been met.Damage to implant compromises performance.Due to damaged implant through additional surgical steps not defined in surgical technique, but required due to patient needs: possible, as it cannot be excluded based on the available information.Conclusion summary: it was reported that the ball-taper and the dome were stuck upon assembly, as the surgeon tried to freely move the ball-taper within the dome.No product were available for an investigation, as the implantation was completed successfully.Therefore the reported event could not be recreated.The review of the manufacturing documents confirms that the products met all specifications to perform as intended.The surgical technique describes how to assemble the dome and ball-taper.Based on the available information, an exact root cause could not be determined.The need for corrective measures is not indicated and zimmer gmbh considers this case as closed.Zimmer biomet¿s reference number of this file is (b)(4).

• Brand Name: ANATOMICAL SHOULDER DOMELOCK, DOME, CENTRIC
• Type of Device: ANATOMICAL SHOULDER DOMELOCK
• Manufacturer (Section D): ZIMMER GMBH; sulzer allee 8; sulzer industrie park; winterthur 8404 ; SZ 8404
• MDR Report Key: 7751808
• MDR Text Key: 116068985
• Report Number: 0009613350-2018-00730
• Device Sequence Number: 1
• Product Code: HSD
• Combination Product (y/n): N
• PMA/PMN Number: PK142403
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional
• Type of Report: Initial,Followup
• Report Date: 12/27/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/06/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 11/30/2022
• Device Model Number: N/A
• Device Catalogue Number: 01.04227.005
• Device Lot Number: 2932677
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 12/18/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: N/A
• Patient Sequence Number: 1