MAUDE Adverse Event Report: ZIMMER BIOMET, INC. CPS SHORT ANCHOR PLUG 20MM; PROSTHESIS, HIP

Model Number N/A

Device Problems Positioning Failure (1158); Material Deformation (2976); Appropriate Term/Code Not Available (3191)

Patient Problems No Known Impact Or Consequence To Patient (2692); No Information (3190)

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Product has been received by zimmer biomet and the investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.If any further information is found which would change or alter any conclusions or information, a follow-up mdr will be submitted accordingly.Zimmer biomet will continue to monitor for trends.

Event Description

It was reported that during a right total knee arthroplasty procedure, the holes in the implant which receive the transverse pins had metal burrs or shavings and would not accept the drill bit or transverse pins.The implant was unusable.The surgeon had to ream up two more millimeters to accommodate 22mm short compress anchor.There was a fifteen minute delay in the procedure.

Event Description

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

Manufacturer Narrative

This follow-up report is being submitted to relay additional information.Implant date : the device was never implanted.Complaint sample was evaluated and the reported event was confirmed.Visual examination of the returned product and the provided pictures identified burrs as reported in the transverse pin holes.Dimensional analysis of the product found that the diameter of all five transverse pin holes were non-conforming to print specifications.Review of the device history records identified no deviations or anomalies during manufacturing.The root cause of the reported issue is attributed to a manufacturing deficiency as the thru holes were not 100% inspected as required per the inspection criteria in place at the time of manufacture.A corrective action has been initiated to address this confirmed event.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: CPS SHORT ANCHOR PLUG 20MM
• Type of Device: PROSTHESIS, HIP
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 56 e. bell drive; warsaw IN 46582
• MDR Report Key: 7951571
• MDR Text Key: 123243481
• Report Number: 0001825034-2018-09561
• Device Sequence Number: 1
• Product Code: KWA
• Combination Product (y/n): N
• PMA/PMN Number: PK062998
• 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: 05/30/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/10/2018
• 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: 178562
• Device Lot Number: 608740
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/20/2018
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 05/28/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: N/A
• Patient Sequence Number: 1