MAUDE Adverse Event Report: ZIMMER BIOMET, INC. CPS TRANSVERSE PIN 6PK 28MM; PROSTHESIS, KNEE

Model Number	N/A
Medical Device Problem Codes	Detachment of Device or Device Component (2907); Noise, Audible (3273); Migration (4003)
Health Effect - Clinical Codes	Osteopenia/ Osteoporosis (2651); Patient Problem/Medical Problem (2688); No Code Available (3191)
Date of Event	04/11/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(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#: 178544; cps centering sleeve 22mm; lot# 903010.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, 0001825034-2020-00480.
Event or Problem 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.
Event or Problem Description
No further event information available at the time of this report.
Additional 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.

• Brand Name: CPS TRANSVERSE PIN 6PK 28MM
• Common Device Name: PROSTHESIS, KNEE
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 56 e. bell drive; warsaw IN 46582
• MDR Report Key: 9667663
• Report Number: 0001825034-2020-00481
• Device Sequence Number: 11452262
• Product Code: KRO
• UDI-Device Identifier: 00880304260511
• UDI-Public: (01)00880304260511
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: K031804
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2019
• Device Explanted Year: 2019
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 02/05/2020

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?: Yes
• Operator of Device: Health Professional
• Device Model Number: N/A
• Device Catalogue Number: 178526
• Device Lot Number: 965300
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 01/16/2020
• Supplement Date Received by Manufacturer: 02/04/2020
• Initial Report FDA Received Date: 02/04/2020
• Supplement Report FDA Received Date: 02/05/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• If action reported to FDA under 21 USC 360i(g), list FDA-assigned Recall Number or include a statement: N/A
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: SEE H10
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention
• Patient Age: 39 YR