MAUDE Adverse Event Report: ZIMMER BIOMET, INC. SHELL POROUS WITH CLUSTER HOLES 56 MM; PROSTHESIS, HIP

Model Number N/A

Device Problem Separation Failure (2547)

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

Event Date 05/08/2018

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Concomitant medical products: zimmer trilogy longevity constrained liner, (ref.No.00-6334-056-32, lot no.62148214).Zimmer hip system femoral head, (ref.No.00801803202, lot no.62268545).Zimmer natural hip system, (ref.No.735402201, lot no.62177154).Customer has indicated that the product will not be returned to zimmer biomet for investigation.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 - 04471.

Event Description

It was reported by legal that this patient underwent an initial right hip arthroplasty and subsequently was revised five years later.During this revision procedure it is noted that the locking mechanism on the shell was not functioning properly.Attempts were made to obtain additional information; however, none was available.

Manufacturer Narrative

(b)(4).This follow-up report is being submitted to relay additional information.Reported event was confirmed by review of medical records.Device history record (dhr) was reviewed and no discrepancies were found.Root cause was unable to be determined.Medical records identified that during the procedure the surgeon attempted to pull the tabs of the locking ring apart but they were already partially apart.The locking mechanism was not functioning properly and an osteotome had to be used to deform the liner enough to remove it.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: SHELL POROUS WITH CLUSTER HOLES 56 MM
• Type of Device: PROSTHESIS, HIP
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 56 e. bell drive; warsaw IN 46582
• MDR Report Key: 9199055
• MDR Text Key: 167597175
• Report Number: 0001822565-2019-04468
• Device Sequence Number: 1
• Product Code: LPH
• Combination Product (y/n): N
• PMA/PMN Number: K093561
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer,distributor,health p
• Type of Report: Initial,Followup
• Report Date: 02/13/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 10/31/2022
• Device Model Number: N/A
• Device Catalogue Number: 00620205622
• Device Lot Number: 62186326
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 09/25/2019
• Initial Date FDA Received: 10/16/2019
• Supplement Dates Manufacturer Received: 02/12/2020
• Supplement Dates FDA Received: 02/13/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: N/A
• Patient Sequence Number: 1