MAUDE Adverse Event Report: ZIMMER BIOMET, INC. ALL POLY PATELLA SIZE 2 8 MM THICKNESS; PROSTHESIS, KNEE

Model Number	N/A
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Aspiration/Inhalation (1725); Pain (1994); Swelling (2091); Ambulation or Postural Difficulties (2544)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).Concomitant medical products: gender solutions male (gsm) femoral component nonporous size 3, left catalog 00541001601 lot 63965464, nonporous stemmed tibial baseplate size 4 left catalog 630700240 lot 63882742, articular surface congruent "size 3 4 catalog 00542401313 lot 63988427, all poly patella size 2 8 mm thickness catalog 00542000802 lot 63995320.The investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.
Event or Problem Description
Patient reports experiencing pain, swelling, and tenderness in the left knee approximately one year post knee arthroplasty.Fluid has been drained from the knee three times.Patient reported an additional knee aspiration and continued pain and discomfort with their knee, especially when descending stairs, sitting, and standing.
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.Was reviewed and no discrepancies relevant to the reported event were found.Root cause was unable to 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: ALL POLY PATELLA SIZE 2 8 MM THICKNESS
• Common Device Name: PROSTHESIS, KNEE
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 56 e. bell drive; warsaw IN 46582
• MDR Report Key: 9378835
• Report Number: 0001822565-2019-05046
• Device Sequence Number: 10885324
• Product Code: MBH
• UDI-Device Identifier: 00889024189607
• UDI-Public: (01)00889024189607
• Combination Product (Y/N): N
• Initial Reporter State: OR
• Initial Reporter Country: US
• PMA/510(K) Number: K071107
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2018
• Reporter Type: Manufacturer
• Report Source: consumer
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 12/30/2019

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: 04/30/2023
• Device Model Number: N/A
• Device Catalogue Number: 00542000802
• Device Lot Number: 63995320
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 11/04/2019
• Supplement Date Received by Manufacturer: 12/20/2019
• Initial Report FDA Received Date: 11/26/2019
• Supplement Report FDA Received Date: 12/30/2019
• 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: Other
• Patient Weight: 84