MAUDE Adverse Event Report: ZIMMER BIOMET, INC. ARTICULAR SURFACE WITH LOCKING SCREW "SIZE GREEN/E F 17 MM HEIGHT"; PROSTHESIS, KNEE

Model Number	N/A
Medical Device Problem Code	Material Twisted/Bent (2981)
Health Effect - Clinical Code	Loss of Range of Motion (2032)
Date of Event	08/06/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).Medical devices: stem extension offset long 12mm dia x 155mm length(combined length 200mm) catalog#: 00598802112 lot#: 63915113, femoral component option for cemented use only size f right catalog#: 00599401692 lot#: 63911107, trabecular metal posterior femoral augment block catalog#: 00549003601 lot#: 63698934, stem extension straight long 14mm dia x 155mm length(combined length 200mm) catalog#: 00598801114 lot#: 63321588, trabecular metal femoral diaphyseal cone, 30mm, medium, right catalog#: 00545001831 lot#: 63694780, trabecular metal tibial half block augment tapered right lateral / left medial with screws catalog#: 00544800528 lot#: 63643642, nexgen a/p wedge tib sizes 3-8 catalog#: 97-5988-050-00 lot#: 64020839, trabecular metal tibial cone, medium 36x31mm catalog#: 00545001336 lot#: 63528077, cobalt g-hv bone cement 40g catalog#: 600-15-100 lot#: 607620, cobalt g-hv bone cement 40g catalog#: 600-15-100 lot#: 253740.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.
Event or Problem Description
It was reported that patient underwent right knee revision approximately two years post-implantation due to medial and literal laxity.X-rays indicated the knee was in varus.Upon removal, the tibial insert was found to have a bent peg.No additional patient consequences were reported.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay additional information.Complaint sample was evaluated and the reported event was confirmed.Visual examination of the returned product shows signs of implantation.Implant found to deformed at the post.The locking mechanism had flared damages.Device history record was reviewed and no discrepancies were found.Root cause was unable to be determined.A summary of the investigation has been sent to the complainant.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 GREEN/E F 17 MM HEIGHT"
• Common Device Name: PROSTHESIS, KNEE
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 56 e. bell drive; warsaw IN 46582
• MDR Report Key: 10463698
• Report Number: 0001822565-2020-03062
• Device Sequence Number: 19555442
• Product Code: JWH
• UDI-Device Identifier: 00889024225138
• UDI-Public: (01)00889024225138(17)251031(10)63823896
• Combination Product (Y/N): N
• Initial Reporter State: WI
• Initial Reporter Country: US
• PMA/510(K) Number: K173057
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2018
• Device Explanted Year: 2020
• Reporter Type: Manufacturer
• Report Source: company representative,distri
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 12/29/2020

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 Expiration Date: 10/31/2025
• Device Model Number: N/A
• Device Catalogue Number: 00599404017
• Device Lot Number: 63823896
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/11/2020
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 08/06/2020
• Supplement Date Received by Manufacturer: 12/28/2020
• Initial Report FDA Received Date: 08/27/2020
• Supplement Report FDA Received Date: 12/29/2020
• 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: 43 YR
• Patient Weight: 155