MAUDE Adverse Event Report: ZIMMER BIOMET, INC. FRDM CNSTR HD 36MM T12/14 -3MM; PROSTHESIS, HIP

Model Number N/A

Device Problem Positioning Failure (1158)

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

Event Date 01/21/2020

Event Type  malfunction  

Manufacturer Narrative

(b)(4) report source: foreign: (b)(6).Customer has indicated that the product is in process of being returned to zimmer biomet for investigation.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: 0002648920-2020-00071.

Event Description

It was reported that during an initial tha, the taper would not engage with the stem.Attempts have been made and additional information on the reported event is unavailable at this time.

Manufacturer Narrative

This follow-up report is being submitted to relay additional information.D4: udi#: (b)(4).The following sections were updated/corrected updated: b4, b5, g4, g7, h2, h3, h6, h10 the reported products were reviewed for compatibility and it was determined that the combination of femoral stem and femoral head utilized is not compatible.Dhr was reviewed and no discrepancies relevant to the reported event were found.Per the ifu for the free constrained liner system, use biomet® femoral and freedom¿ modular head component with appropriate matching type i taper or 12/14 taper.Additionally, the product's label mentions the legal manufacturer of the product to help the user distingush between biomet and zimmer products.Therefore, the root cause can be attributed to use error.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: FRDM CNSTR HD 36MM T12/14 -3MM
• Type of Device: PROSTHESIS, HIP
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 56 e. bell drive; warsaw IN 46582
• MDR Report Key: 9681024
• MDR Text Key: 178641976
• Report Number: 0001825034-2020-00568
• Device Sequence Number: 1
• Product Code: LPH
• Combination Product (y/n): N
• PMA/PMN Number: K043537
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,foreign,health pr
• Type of Report: Initial,Followup
• Report Date: 05/26/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/07/2020
• 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: 14-107017
• Device Lot Number: 908890
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 05/22/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: N/A
• Patient Sequence Number: 1
• Treatment: CAT#:00811400010 ZIMMER STEM LOT#: 64536407