MAUDE Adverse Event Report: ZIMMER BIOMET, INC. PARTIAL TIBIAL CEMENTED SIZE D LEFT MEDIAL; PROTHESIS, 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)
Date of Event	07/10/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).Concomitant medical products: 42558000301 - femoral component - 63607288; 42518200408 - articular surface - 63424640.The customer has indicated that the product will not be returned to zimmer biomet for investigation, as it remains implanted.The investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.Multiple mdr reports were filed for this event, please see associated reports: 3007963827-2021-00027, 0001822565-2021-00328.
Event or Problem Description
It was reported that patient underwent left unilateral knee arthroplasty.At the one & two year visits, the patient reports moderate pain, noise, and feeling of instability.The patient was diagnosed with pes anserine bursitis without reported treatment or intervention and a neuroma for which the patient received oral medication for nerve pain.At the two year visit, the patient reported persistent pain with no clinical indication of device complications.The patient was instructed to return in 5 years.
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.The following sections were updated: b4; b5; g3; g6; h1; h2; h3; h6 no product was returned or pictures provided; visual and dimensional evaluations could not be performed.The dhr was reviewed and no discrepancies relevant to the reported event were found.Medical records were provided and reviewed by a health care professional.Review found at 1 year follow up patient had pain with normal alignment and stability.X-rays have no significant radiographic findings.Pain with activities and clicking.Treated with ibuprofen.Continues to have swelling.At 1.5 year check in symptoms have improved but continues to have pain with activity, swelling, and instability, feels as though knee buckles.Diagnosed with neuroma, prescribed gabapentin for nerve pain.Patient has a history of fibromyalgia and chronic pain.At 2 year follow up continues to have pain, small effusion and satisfactory rom.Xrays reveal good prosthesis alignment, satisfactory hardware placement, no evidence of prosthesis loosening.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.

• Brand Name: PARTIAL TIBIAL CEMENTED SIZE D LEFT MEDIAL
• Common Device Name: PROTHESIS, KNEE
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 56 e. bell drive; warsaw IN 46582
• MDR Report Key: 11285679
• Report Number: 0001822565-2021-00329
• Device Sequence Number: 11633434
• Product Code: HSX
• UDI-Device Identifier: 00880304812666
• UDI-Public: (01)00880304812666(17)270131(10)63441156
• Combination Product (Y/N): N
• Initial Reporter State: NM
• Initial Reporter Country: US
• PMA/510(K) Number: K161592
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2017
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 04/13/2021

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: 42538000401
• Device Lot Number: 63441156
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 01/15/2021
• Supplement Date Received by Manufacturer: 04/13/2021
• Initial Report FDA Received Date: 02/05/2021
• Supplement Report FDA Received Date: 04/13/2021
• 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
• Outcome Attributed to Adverse Event: Other
• Patient Weight: 88