MAUDE Adverse Event Report: ZIMMER BIOMET, INC. ECHO POR FMRL LAT NC 12X140MM; HIP PROSTHESIS

Model Number N/A

Device Problem Inadequacy of Device Shape and/or Size (1583)

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

Event Date 03/20/2019

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Product has been received by zimmer biomet and the investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.Multiple mdr reports were filed for this event, please see associated reports: 0001825034-2019-01545.

Event Description

It was reported that during a primary implant surgery the stems were undersized/ smaller than the broach trial.Other stem products were used to complete surgery.Additional information was requested, however no information was available.

Manufacturer Narrative

This follow-up report is being submitted to relay additional information.Udi: (b)(4).Complaint sample was evaluated and the reported event was not confirmed.Two stems were returned and evaluated against the complaint.Visual inspection of each stem, no significant scuffing or scratching was observed for either stem.Both stems were measured to confirm they are consistent stem overall length and ap and ml width of porous coating.Both stems conform to print criteria for identification.The profile of both stems conforms to the respective mylar overlays.Device history records (dhr) were reviewed and no discrepancies relevant to the reported event were found.Root cause could not be determined with information available.A summary of the investigation has been sent to the complainant.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: ECHO POR FMRL LAT NC 12X140MM
• Type of Device: HIP PROSTHESIS
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 56 e. bell drive; warsaw IN 46582
• MDR Report Key: 8514966
• MDR Text Key: 141969570
• Report Number: 0001825034-2019-01546
• Device Sequence Number: 1
• Product Code: LZO
• Combination Product (y/n): N
• PMA/PMN Number: K070274
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,health profession
• Type of Report: Initial,Followup
• Report Date: 04/26/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/15/2019
• 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: 192112
• Device Lot Number: 759620
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 04/15/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: N/A
• Patient Sequence Number: 1
• Patient Age: 55 YR
• Patient Weight: 95