MAUDE Adverse Event Report: ZIMMER BIOMET, INC. ECHO POR FEMORAL NC 15X155MM; PROSTHESIS, HIP

Model Number N/A

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Host-Tissue Reaction (1297); No Information (3190)

Event Date 10/09/2018

Event Type  Injury  

Manufacturer Narrative

(b)(4).Concomitant medical devices: catalog number: us157854 lot number:160270 brand name: m2a magnum cup; catalog number:157448 lot number:505290 brand name: m2a magnum head; catalog number: 192015 lot number:407340 brand name: echo por fmrl nc; catalog number: 139254 lot number: 452400 brand name: m2a magnum taper insert.Multiple mdr reports were filed for this event, please see associated reports: 0001825034-2020-02455, 0001825034-2020-03540, 0001825034-2020-02456.Reported event was unable to be confirmed due to limited information received from the customer.Device history record was reviewed and no discrepancies were found.Root cause was unable to be determined as the necessary information to adequately investigate the reported event was not provided.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.Device not returned for evaluation.

Event Description

It was reported that the patient was revised due to unknown reasons approximately 8 years post implantation.Attempts have been made and additional information on the reported event is unavailable.

Manufacturer Narrative

This follow-up report is being submitted to relay additional information.Medical records were provided and reviewed by a health care professional.Review of the available records identified the following: pathology report reviewed.Findings include pseudotumor left hip from soft tissue collection and acetabular shell and femoral head submitted for gross analysis only.The additional information does not change the outcome of the previous investigation.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

It was reported that the patient was revised approximately 8 years post implantation due to pseudotumor.No further event information available at the time of this report.

• Brand Name: ECHO POR FEMORAL NC 15X155MM
• Type of Device: PROSTHESIS, HIP
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 56 e. bell drive; warsaw IN 46582
• MDR Report Key: 10541782
• MDR Text Key: 207190390
• Report Number: 0001825034-2020-03539
• Device Sequence Number: 1
• Product Code: MEH
• Combination Product (y/n): N
• PMA/PMN Number: K070274
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,consum
• Type of Report: Initial,Followup
• Report Date: 01/21/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/16/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 06/30/2020
• Device Model Number: N/A
• Device Catalogue Number: 192015
• Device Lot Number: 407340
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 01/13/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: N/A
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 62 YR