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

Model Number N/A

Device Problem Difficult to Insert (1316)

Patient Problem No Information (3190)

Event Date 12/19/2018

Event Type  malfunction  

Manufacturer Narrative

(b)(4).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.

Event Description

It was reported that the implant did not seat on the neck of the stem.The procedure was completed with another size head.No additional information was available.

Event Description

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

Manufacturer Narrative

Concomitant medical products: 14-107017, frdm cnstr hd 36mm t12/14 -3mm, 056430, 14-107018, frdm cnstr hd 36mm t12/14 std, 986970, 00585003238, proximal femoral component 38 mm offset, 63705472.Complaint sample was evaluated and the reported event was confirmed.Dhr was reviewed and no discrepancies were found.The biomet head is not supposed to be used with zimmer stem.Therefore, the root cause can be attributed to user error.A summary of the investigation was sent to the complainant conveying proper surgical technique and use of the device.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.

• 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: 8253229
• MDR Text Key: 133238175
• Report Number: 0001825034-2019-00023
• 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,health profession
• Type of Report: Initial,Followup
• Report Date: 03/08/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/16/2019
• 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: 14-107017
• Device Lot Number: 297100
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/16/2019
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 03/07/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: N/A
• Patient Sequence Number: 1
• Patient Age: 72 YR