MAUDE Adverse Event Report: ZIMMER BIOMET, INC. FEMORAL STEM 12/14 NECK TAPER; PROSTHESIS, HIP

Model Number N/A

Device Problem Insufficient Information (3190)

Patient Problem No Information (3190)

Event Date 12/20/2010

Event Type  Injury  

Manufacturer Narrative

(b)(4).Concomitant medical products: 00801804002 ¿ cocr femoral head ¿ 61558084, 00620205822 ¿ shell ¿ 61544391, 00630505840 ¿ liner ¿ 61540471.Customer has indicated the product will not be returned to zimmer biomet for the investigation as the product location is unknown.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: 0001822565 - 2019 - 05471, 0002648920 - 2019 - 00922.

Event Description

It was reported that patient underwent a left hip revision approximately 2 days post implantation, a second revision approximately 6 months late, a third revision approximately 9 months later, a fourth revision approximately 3 months after that, and a fifth revision approximately 3 months later due to unknown reasons.The stem, head and liner components were removed and replaced.Attempts have been made and additional information on the reported event is unavailable at this time.

Event Description

No additional event information to report at this time.

Manufacturer Narrative

This follow-up report is being submitted to relay additional information.The following sections were updated/corrected updated: g4; h2; h3; h6 reported event was unable to be confirmed due to limited information provided by the customer.Dhr was reviewed and no discrepancies were found.The root cause is 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.

• Brand Name: FEMORAL STEM 12/14 NECK TAPER
• Type of Device: PROSTHESIS, HIP
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 56 e. bell drive; warsaw IN 46582
• MDR Report Key: 9526754
• MDR Text Key: 174336371
• Report Number: 0001822565-2019-05472
• Device Sequence Number: 1
• Product Code: LZO
• Combination Product (y/n): N
• PMA/PMN Number: K161830
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor
• Type of Report: Initial,Followup
• Report Date: 04/15/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 08/31/2020
• Device Model Number: N/A
• Device Catalogue Number: 00771101220
• Device Lot Number: 61530923
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 12/05/2019
• Initial Date FDA Received: 12/27/2019
• Supplement Dates Manufacturer Received: 04/13/2020
• Supplement Dates FDA Received: 04/15/2020
• 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