MAUDE Adverse Event Report: ZIMMER MANUFACTURING B.V. TIBIAL COMPONENT PEGGED PRECOAT FOR CEMENTED; PROSTHESIS, KNEE

Model Number	N/A
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Wound Dehiscence (1154); Impaired Healing (2378)
Date of Event	12/12/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).Concomitant medical products: item 00595001601 lot 64586126.Item 00595204010 lot 64590069.Customer has indicated that the product will not be returned to zimmer biomet for investigation as the product 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: 3007963827-2021-00055, 0001822565-2021-00667.
Event or Problem Description
It was reported that patient underwent a total knee arthroplasty.Approximately 3 weeks after the procedure patient had a scar revision - skin excision to avoid necrosis, and possible infection.There were no implants removed.Attempts were made and no additional information was provided.
Additional Manufacturer Narrative
(b)(4).It is expected that a wound heals in stages and should be of normal appearance related to the timeframe since the incision was made.A surgical wound should be well approximated without redness, warmth, swelling and/or purulent drainage for the duration of its healing.The expression wound concerns or non-healing wound would imply that the appearance of the wound deviates from what a surgical wound should appear as.It may be red, have drainage, additional pain, warmth and swelling as well as healing time may be delayed.Necrotic tissue can result from a non-healing wound.This deviation signifies an alteration in the wound healing process.As reported a surgical site scar revision was performed due to delayed/altered healing to promote healing and prevent further necrosis.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.
Event or Problem Description
No further event information available at the time of this report.

• Brand Name: TIBIAL COMPONENT PEGGED PRECOAT FOR CEMENTED
• 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: 11462542
• Report Number: 0002648920-2021-00053
• Device Sequence Number: 4624964
• Product Code: JWH
• UDI-Device Identifier: 00889024214460
• UDI-Public: (01)00889024214460(17)300228(10)64645362
• Combination Product (Y/N): N
• Initial Reporter State: CO
• Initial Reporter Country: US
• PMA/510(K) Number: K933785
• 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,distri
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 03/11/2021

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: 00597004502
• Device Lot Number: 64645362
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 02/26/2021
• Supplement Date Received by Manufacturer: 03/11/2021
• Initial Report FDA Received Date: 03/11/2021
• Supplement Report FDA Received Date: 03/12/2021
• 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: SEE H10 NARRATIVE
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention
• Patient Weight: 96