MAUDE Adverse Event Report: ZIMMER BIOMET, INC. CPS CENTERING SLEEVE 22MM; PROSTHESIS, KNEE

Model Number N/A

Device Problems Detachment of Device or Device Component (2907); Noise, Audible (3273); Migration (4003)

Patient Problems Osteopenia/ Osteoporosis (2651); Patient Problem/Medical Problem (2688); No Code Available (3191)

Event Date 04/11/2019

Event Type  Injury  

Manufacturer Narrative

(b)(4).(udi): (b)(4).Associated products : item#: 178364; cps xs sht spdl w pins 800lbf; lot# 662280, item#: 178562; cps short anchor plug 20mm; lot# 608710, item#: 178526; cps transverse pin 6pk 28mm; lot# 965300.Customer has indicated that the product will not be returned to zimmer biomet for investigation, as its 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: 0001825034-2019-03992, 0001825034-2020-00479, 0001825034-2020-00481.

Event Description

It is reported that the patient underwent a left knee arthroplasty revision to address tibial component loosening approximately two (2) months post-operatively.Initial operative notes reported that the patient had very thin tibial bone, which required additional cuts for implant placement.Revision operative notes reported that the implant was clearly loose at its bone interface and had collapsed down on the bone completely.The compress device was removed and placed again using five (5) cross pins and loading 600 pounds of compression.A centering sleeve and spindle were also placed to fit the tibia.

Manufacturer Narrative

This follow-up report is being submitted to relay additional information.The following sections were updated: b4; b5; g4; g7; h1; h2; h3; h6.Reported event was confirmed by review of medical records, which identified patient has audible clicking and radiographs show anchor plug has collapsed with loosening of hardware.During the revision procedure the implant was noted to be frankly loose at its bone interface as it had collapsed down the bone completely.Device history record (dhr) was reviewed and no discrepancies relevant to the reported event were found.Investigation results concluded that the reported event is considered to be a previously addressed design issue.If any further information is found which would change or alter any conclusions or information, a supplemental report 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: CPS CENTERING SLEEVE 22MM
• Type of Device: PROSTHESIS, KNEE
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 56 e. bell drive; warsaw IN 46582
• MDR Report Key: 9667667
• MDR Text Key: 177802629
• Report Number: 0001825034-2020-00480
• Device Sequence Number: 1
• Product Code: KRO
• UDI-Device Identifier: 00880304260696
• UDI-Public: (01)00880304260696
• Combination Product (y/n): N
• PMA/PMN Number: K031804
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial,Followup
• Report Date: 02/05/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/04/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: N/A
• Device Catalogue Number: 178544
• Device Lot Number: 903010
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 02/04/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: N/A
• Patient Sequence Number: 1
• Treatment: SEE H10
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 39 YR