MAUDE Adverse Event Report: ZIMMER BIOMET, INC. FEMORAL COMPONENT; PROSTHESIS, KNEE

Model Number	N/A
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Pain (1994); Swelling (2091); Reaction (2414); Ambulation or Postural Difficulties (2544)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).Customer has indicated that the product will not be returned to zimmer biomet for investigation, as the product remains implanted.Concomitant medical devices: item number: 00598800300, wedged tibial plate,  lot: 63506369; item number: 00545001730, femoral cone,  lot: 63392061; item number: 00544705336, tibial cone,  lot: 62380724;        item number: 00598801014, stem implant,     lot: 63260023; item number: 00549003410, distal femoral augment,  lot: 63141884; item number: 00549003410, distal femoral augment,  lot: 63322074;   item number: 00598801012, stem implant, lot: 63390299; item number: unknown, unknown bearing, lot: unknown.Multiple mdr reports were filed for this event, please see associated reports: 0001822565 - 2020 - 03653, 0001822565 - 2020 - 03663, 0001822565 - 2020 - 03664.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 patient is experiencing pain, swelling, difficulty ambulating and a possible allergic reaction to nickel and chromium approximately 4 years post-implantation.No medical intervention has been reported to date.Attempts have been made and no additional information is available at this time.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay additional information.Reported event was unable to be confirmed due to limited information received from the customer.Device history record (dhr) was reviewed and no discrepancies were found.A definitive root cause cannot be determined.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.
Event or Problem Description
No further event information available at the time of this report.

• Brand Name: FEMORAL COMPONENT
• Common Device Name: PROSTHESIS, KNEE
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 56 e. bell drive; warsaw IN 46582
• MDR Report Key: 10756242
• Report Number: 0001822565-2020-03652
• Device Sequence Number: 17103993
• Product Code: JWH
• UDI-Device Identifier: 00889024224780
• UDI-Public: (01)00889024224780
• Combination Product (Y/N): N
• Initial Reporter State: AZ
• Initial Reporter Country: US
• PMA/510(K) Number: K173057
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2016
• Reporter Type: Manufacturer
• Report Source: distributor,health profession
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 01/19/2021

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?: No
• Operator of Device: Health Professional
• Device Expiration Date: 04/30/2026
• Device Model Number: N/A
• Device Catalogue Number: 00599401491
• Device Lot Number: 63348326
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 10/05/2020
• Supplement Date Received by Manufacturer: 01/19/2021
• Initial Report FDA Received Date: 10/29/2020
• Supplement Report FDA Received Date: 01/20/2021
• 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: PLEASE SEE H10 NARRATIVE.
• Outcome Attributed to Adverse Event: Other