MAUDE Adverse Event Report: ZIMMER BIOMET, INC. ARTICULAR SURFACE WITH LOCKING SCREW SIZE GH 17 MM HEIGHT; PROSTHESIS, KNEE

Model Number	N/A
Medical Device Problem Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Codes	No Code Available (3191); Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available (4581)
Date of Event	12/24/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).Customer has indicated that the product is in process of being returned to zimmer biomet for investigation.Once the investigation has been completed, a follow-up mdr will be submitted.Additional associated products and mdrs.00598004702 stemmed tibial component precoat size 6 for cemented use only lot# 64500601.Mdr: 0002648920 - 2020 - 00545.
Event or Problem Description
It was reported that approximately 1 month post implantation, the patient was revised of the tibial components due to disassembly of the articular surface and tibial tray.No additional information at the time of this report.
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.Visual examination of the returned product identified signs of being in-vivo.The articular surface dovetail shows flared damage and the tibial plate shows bone cement adhered to it.No locking screw was returned.Review of the device history record(s) identified no deviations or anomalies during manufacturing.Radiographs were provided and reviewed by a health care professional.Review of the available records identified the following: flat metallic lps flex articular surface structure disassembled from the tibial baseplate.No locking screw was identified.The complaint is confirmed.The root cause is attributed to the user not following instructions as the surgeon didn't use a locking screw for 17mm lps-flex articular surface to lock on to the tibial plate.Per the package insert: stated on page 6 that all cr flex and lps flex 17, 20 and 23 mm articular surfaces require a locking screw to fasten the articular surface to the tibial baseplate.No corrective actions, preventive actions, or field actions resulted after the investigation of this event.

• Brand Name: ARTICULAR SURFACE WITH LOCKING SCREW SIZE GH 17 MM HEIGHT
• Common Device Name: PROSTHESIS, KNEE
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 56 e. bell drive; warsaw IN 46582
• MDR Report Key: 11090360
• Report Number: 0001822565-2020-04254
• Device Sequence Number: 16811045
• Product Code: JWH
• UDI-Device Identifier: 00889024212091
• UDI-Public: (01)00889024212091
• 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): 06/03/2021

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 Model Number: N/A
• Device Catalogue Number: 00596404217
• Device Lot Number: 64324213
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 12/28/2020
• Supplement Date Received by Manufacturer: 06/01/2021
• Initial Report FDA Received Date: 12/29/2020
• Supplement Report FDA Received Date: 06/03/2021
• 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
• Concomitant Medical Products and Therapy/Usage Dates: SEE H10 NARRATIVE.
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention
• Patient Weight: 99