MAUDE Adverse Event Report: ZIMMER BIOMET, INC. STEMMED TIBIAL 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 products: 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 - 03652.0001822565 - 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
Upon reassessment of the reported event, it was determined to be not reportable.This device did not cause or contribute towards the reported event.The initial report was forwarded in error and should be voided.
Event or Problem Description
No further event information available at the time of this report.

• Brand Name: STEMMED TIBIAL COMPONENT
• Common Device Name: PROSTHESIS, KNEE
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 56 e. bell drive; warsaw IN 46582
• MDR Report Key: 10756259
• Report Number: 0001822565-2020-03653
• Device Sequence Number: 3840710
• Product Code: JWH
• UDI-Device Identifier: 00889024220218
• UDI-Public: (01)00889024220218
• Combination Product (Y/N): N
• Initial Reporter State: AZ
• Initial Reporter Country: US
• PMA/510(K) Number: K933785
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2016
• Reporter Type: Manufacturer
• Report Source: consumer,distributor,health p
• 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 Model Number: N/A
• Device Catalogue Number: 00598800300
• Device Lot Number: 63506369
• 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: 01/12/2021
• 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