MAUDE Adverse Event Report: ZIMMER BIOMET, INC. ARCOS 16 X 200MM STEM TRL; PROSTHESIS HIP

Model Number N/A

Device Problem Failure to Disconnect (2541)

Patient Problem No Information (3190)

Event Date 09/07/2018

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Concomitant medical products: arcos sz e body broach 60mm, pn 31-301105, ln 682922.Report source: (b)(6).Multiple mdr reports were filed for this event.Please see reports: 0001825034-2018-09351.Customer has indicated that the product will be returned to zimmer biomet for investigation.The investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.

Event Description

It was reported that an instrument was unable to disconnect broach body from the trial stem.Attempts have been made and additional information on the reported event is unavailable at this time.No further information is available.

Manufacturer Narrative

This follow-up report is being submitted to relay additional information.If any further information is found which would change or alter any conclusions or information, a supplemental will be filed accordingly.Zimmer biomet will continue to monitor for trends.

Event Description

No further event information available at the time of this report.

Manufacturer Narrative

(b)(4).Concomitant medical products- arcos body broach, catalog #: 31-301103 lot #: 7592540.Reported event was confirmed by review of visual inspection of the devices identified the two parts were stuck together.The body broach has impact damages likely caused while trying to remove the broach from the stem.The distal portion of the trial stem has impact damages and likely caused the stem to stuck inside the broach.The screw that locked the broach and trial was able to be unlocked and locked into position.However, with the screw in the fully removed position, the broach was unable to be separated from the stem without the possibility of damaging either part.Device history record (dhr) was reviewed and no discrepancies relevant to the reported event were found.Root cause was unable to be determined.If any further information is found which would change or alter any conclusions or information, a supplemental will be filed accordingly.Zimmer biomet will continue to monitor for trends.

Event Description

No further event information available at the time of this report.

• Brand Name: ARCOS 16 X 200MM STEM TRL
• Type of Device: PROSTHESIS HIP
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 56 e. bell drive; warsaw IN 46582
• MDR Report Key: 7937757
• MDR Text Key: 122798688
• Report Number: 0001825034-2018-09351
• Device Sequence Number: 1
• Product Code: JDI
• Combination Product (y/n): N
• PMA/PMN Number: PK090757
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,foreign,health pr
• Type of Report: Initial,Followup,Followup
• Report Date: 07/19/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/05/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: N/A
• Device Catalogue Number: 31-301616
• Device Lot Number: 7851208
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/07/2018
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 07/16/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: N/A
• Patient Sequence Number: 1