MAUDE Adverse Event Report: ZIMMER MANUFACTURING B.V. OPTION ST TIB PLT SIZE 5; PROSTHESIS, KNEE

Model Number	N/A
Medical Device Problem Codes	Loss of or Failure to Bond (1068); Loosening of Implant Not Related to Bone-Ingrowth (4002)
Health Effect - Clinical Code	No Information (3190)
Date of Event	12/12/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).Medical products: articular surface size ef 10 mm height item# 00596204010 lot# 63796439, lps-flex option femoral f-l item# 00596401651 lot# 63955715.Report source: (b)(6).Customer has indicated that the product will be returned to zimmer biomet for investigation.The investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.
Event or Problem Description
It was reported that a patient was revised approximately fourteen months¿ post implantation due to tibial loosening.No indication for infection.The tibial component was loose in the cement.The cement was partial well fixed to the bone.There is no additional information at this time.
Additional Manufacturer Narrative
This report is being submitted to report the associated bone cement.Medical products palacos r+g 40 gram/2x item# unknown lot# unknown.
Event or Problem Description
No further event information available at the time of this report.
Additional Manufacturer Narrative
This follow-up is being submitted to relay additional information.Updated: b4, b5, d10, g4, g7, h1, h2, h3, h6, and h10.Visual examination of the returned product found signs of being implanted.Dimensional analysis of the product determined that the product, where measured, was conforming to print specifications.X-rays were provided and reviewed by a healthcare professional.Review found interval loosening and slight medial subsidence of the tibial implant.Increased density within the tibial plateau could represent preceding stress fracture or reactive density due to the subsidence noted.Bone is osteopenic.Device history record (dhr) was reviewed for deviations and/ or anomalies with no deviations / anomalies identified.A definitive root cause cannot 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: OPTION ST TIB PLT SIZE 5
• Common Device Name: PROSTHESIS, KNEE
• Manufacturer (Section D): ZIMMER MANUFACTURING B.V.; turpeaux industrial park; route #1 km 123.4 bldg #1; mercedita PR 00715
• MDR Report Key: 9495378
• Report Number: 0002648920-2019-00900
• Device Sequence Number: 19352638
• Product Code: JWH
• UDI-Device Identifier: 00889024218857
• UDI-Public: (01)00889024218857
• Combination Product (Y/N): N
• Initial Reporter Country: NL
• PMA/510(K) Number: K173057
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2018
• Device Explanted Year: 2019
• Reporter Type: Manufacturer
• Report Source: company representative,distri
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 04/16/2020

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: 00598604701
• Device Lot Number: 64057970
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/16/2020
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 12/12/2019
• Supplement Date Received by Manufacturer: 12/31/2019; 04/15/2020
• Initial Report FDA Received Date: 12/19/2019
• Supplement Report FDA Received Date: 12/31/2019; 04/16/2020
• 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
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention
• Patient Age: 58 YR
• Patient Weight: 108