MAUDE Adverse Event Report: ZIMMER BIOMET, INC. SHELL WITH CLUSTER HOLES POROUS 52 MM O.D. SIZE II FOR USE WITH II LINERS; PROSTHETIC, HIP

Model Number N/A

Device Problem Defective Device (2588)

Patient Problems No Patient Involvement (2645); No Clinical Signs, Symptoms or Conditions (4582)

Event Type  malfunction  

Manufacturer Narrative

(b)(4).The product has been returned to zimmer biomet for investigation.Once the investigation has been completed, a follow-up mdr will be submitted.

Event Description

It was reported there is a wire sticking out of the implant.It was opened during a surgery but was not used.No further other info on the surgery available.Attempts have been made and additional information on the reported event is unavailable at this time.

Event Description

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

Manufacturer Narrative

The provided picture confirms the device has a protruding wire near the rim of the device.The reported device was returned and inspected, as returned, the protruding fiber metal wire was no longer attached to the device at the time of the evaluation.Review of the device history record(s) identified no deviations or anomalies during manufacturing.Medical records were not provided.The root cause of the reported event can be traced to a manufacturing deficiency.Although it is unclear precisely when the thread came loose from the shell, manufacturing processes are set up in order to prevent this issue.It is inherent to the fiber metal process that a wire may be come dislodged/loose from the shell at some point in the process.It cannot be 100% determined where this wire on this shell came loose, it could be within any process after the bonding cycle.Additional actions are triggered for investigation via correction action process.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: SHELL WITH CLUSTER HOLES POROUS 52 MM O.D. SIZE II FOR USE WITH II LINERS
• Type of Device: PROSTHETIC, HIP
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 56 e. bell drive; warsaw IN 46582
• MDR Report Key: 11046722
• MDR Text Key: 222795015
• Report Number: 0001822565-2020-04170
• Device Sequence Number: 1
• Product Code: JDI
• UDI-Device Identifier: 00880024150171
• UDI-Public: (01)00880024150171
• Combination Product (y/n): N
• PMA/PMN Number: K200823
• 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: 03/31/2021

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 Model Number: N/A
• Device Catalogue Number: 00875305201
• Device Lot Number: 63978519
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/14/2020
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 12/07/2020
• Initial Date FDA Received: 12/21/2020
• Supplement Dates Manufacturer Received: 03/31/2021
• Supplement Dates FDA Received: 03/31/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: N/A
• Patient Sequence Number: 1