MAUDE Adverse Event Report: ZIMMER BIOMET, INC. ARTICULAR SURFACE WITH LOCKING SCREW SIZE EF 23 MM HEIGHT "USE WITH PLATE 5; PROSTHESIS, KNEE

Model Number	N/A
Medical Device Problem Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Codes	Failure of Implant (1924); No Information (3190)
Date of Event	08/09/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).Associated products : item#: 00598004702; stemmed tibial component ; lot#: j6563908.Customer had indicated that the product was being returned to zimmer biomet for investigation, but it has not yet been received.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 - 2020 - 03965.
Event or Problem Description
It was reported a patient underwent a left knee arthroplasty on approximately one year ago.Subsequently, the lps flex articular surface was identified via xray to no longer be attached to stemmed tibial baseplate and revised on 10 months post-op.
Additional Manufacturer Narrative
Reported event was confirmed by review of radiographs reviewed by a third party hcp.Initial image notes normal appearance of total knee arthroplasty and appears to be anatomically aligned and intact.Second image shows metallic articular surface is no longer attached to the tibial base, can be seen detached with the anterior joint space.The remainder of hardware appears intact, bone appears normal.There are no signs of loosening, wear, radiolucency, or contributing factors.Complaint sample was returned and evaluated against the reported event.Visual inspection identified the tibia exhibits signs of repeated use and has some residue on the place.The art surface shows signs of being implanted with discoloration and wear.The dovetail feature is flared out.Dhr was reviewed and no discrepancies were found.The root cause is unable to be determined.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 or Problem Description
No further event information available at the time of this report.

• Brand Name: ARTICULAR SURFACE WITH LOCKING SCREW SIZE EF 23 MM HEIGHT "USE WITH PLATE 5
• Common Device Name: PROSTHESIS, KNEE
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 56 e. bell drive; warsaw IN 46582
• MDR Report Key: 10929631
• Report Number: 0001822565-2020-03966
• Device Sequence Number: 13693109
• Product Code: JWH
• UDI-Device Identifier: 00889024211995
• UDI-Public: (01)00889024211995
• Combination Product (Y/N): N
• Initial Reporter State: NJ
• Initial Reporter Country: US
• PMA/510(K) Number: K173057
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2020
• Device Explanted Year: 2020
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: distributor,health profession
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 03/10/2021

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 Expiration Date: 09/30/2026
• Device Model Number: N/A
• Device Catalogue Number: 00596404023
• Device Lot Number: 64152994
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/06/2021
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 11/05/2020
• Supplement Date Received by Manufacturer: 03/09/2021
• Initial Report FDA Received Date: 12/01/2020
• Supplement Report FDA Received Date: 03/10/2021
• 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
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention
• Patient Weight: 118