MAUDE Adverse Event Report: ZIMMER MANUFACTURING B.V. TIBIAL COMPONENT PEGGED PRECOAT SIZE 5; 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); Loss of Range of Motion (2032); Scar Tissue (2060); Ambulation or Postural Difficulties (2544); Swelling/ Edema (4577)
Date of Event	01/12/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).Multiple mdr reports were filed for this event, please see associated report: 0001822565-2021-01863, 0001822565-2021-01864.Concomitant medical products: femur cemented cruciate retaining (cr) standard nitrided left size 6.Item# 42572606001 lot# 64706621.Articular surface use with plate 5,6 size green/c-h 12 mm height.Item# 00595204012 lot# 64590067.Customer has indicated that the product will be returned to zimmer biomet for investigation.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 that a patient underwent a manipulation under anesthesia approximately 5 and a half months¿ post implantation due to severe pain and arthrofibrosis.Despite cortisone injections and manipulation, the patient continued to have moderate/severe pain and problems at the one year follow up visit.No further intervention has been planned to date.Attempts to obtain additional information have been made; however, no more information is available.
Event or Problem Description
No further event information available at the time of this report.
Additional Manufacturer Narrative
This follow-up is being submitted to relay additional information.No product was returned or pictures provided; therefore, visual and dimensional evaluations could not be performed.Medical records/radiographs were provided and reviewed by a health care professional.Review of the available records identified the following: two days' post op, dressing change.Five days' post op, dressing change.One month follow up fwb with antalgic gait, opioids for pain prn, rom 0-93°, moderate pain, moderate-severe problems, pain 5/10, satisfied.Two months' post op, worsening knee pain.Three month follow up, fwb with normal gait, opioids for pain prn, rom 0-120°, moderate-severe pain/problems, pain 7/10, dissatisfied.Three months and one-week post op, cortisone injection.Four and a half months' post op, strain of patellar tendon caused by repeated stresses or injury to soft tissue.As we know patient had arthrofibrosis and stiffness this strain may be secondary the stiffness the patient was experiencing and patient attempting to compensate.Also it is noted device was not revised or replaced therefore the device can be excluded.Five and a half months' post op, stiffness, arthrofibrosis, mua with cortisone injection.One year follow up, moderate-severe pain/problems.Device history record (dhr) was reviewed for deviations and/ or anomalies with no related deviations / anomalies identified.A definitive root cause cannot be determined.If any further information is found which would change or alter any conclusions or information, a supplemental will be filed accordingly.Zimmer biomet will continue to monitor for trends.

• Brand Name: TIBIAL COMPONENT PEGGED PRECOAT SIZE 5
• Common Device Name: PROSTHESIS, KNEE
• Manufacturer (Section D): ZIMMER MANUFACTURING B.V.; turpeaux industrial park; route #1 km 123.4 bldg #1; mercedita PR 00715
• MDR Report Key: 12135921
• Report Number: 0002648920-2021-00183
• Device Sequence Number: 19054413
• Product Code: JWH
• UDI-Device Identifier: 00889024214453
• UDI-Public: (01)00889024214453(17)300531(10)64740566
• Combination Product (Y/N): N
• Initial Reporter State: CO
• Initial Reporter Country: US
• PMA/510(K) Number: K173057
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2020
• 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): 07/28/2021

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: 00597004501
• Device Lot Number: 64740566
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 06/17/2021
• Supplement Date Received by Manufacturer: 07/27/2021
• Initial Report FDA Received Date: 07/08/2021
• Supplement Report FDA Received Date: 07/28/2021
• 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: 64