MAUDE Adverse Event Report: ZIMMER ORTHOPAEDIC MFG. LTD. ARTICULAR SURFACE FIXED BEARING ULTRACONGRUENT RT 10MM; PROSTHESIS, KNEE

Model Number	N/A
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Skin Infection (4544)
Date of Event	09/29/2021
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported the patient had an initial right total knee arthroplasty.Subsequently about 2 weeks post procedure a mild superficial skin infection was noted and treated with medical intervention that resolved approximately one month post intervention.
Additional Manufacturer Narrative
(b)(4).Customer has indicated that the product will not be returned to zimmer biomet for investigation, as the device remains implanted.The investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.Additional associated products and mdrs: 42502606202 femur cemented cruciate retaining standard right sz 7 lot# 64792416 mdr: 3007963827-2022-00012; 42532006702 tibia cemented 5 degree stemmed right size d lot# 64830697 mdr: 3007963827-2022-00013; 42540000029 all poly patella cemented 29 mm diameter lot# 65061549 mdr: 0002648920-2022-00007.
Additional Manufacturer Narrative
Upon receiving additional information, it was determined that the part referenced should not have been reported.The initial report should be voided.This was a data entry error and has been updated; there was no such event.
Event or Problem Description
Upon receiving additional information, it was determined that the part referenced should not have been reported.The initial report should be voided.

• Brand Name: ARTICULAR SURFACE FIXED BEARING ULTRACONGRUENT RT 10MM
• Common Device Name: PROSTHESIS, KNEE
• Manufacturer (Section D): ZIMMER ORTHOPAEDIC MFG. LTD.; building no 2 east park; shannon industrial estate; shannon, county clare ; EI
• Manufacturer (Section G): ZIMMER ORTHOPAEDIC MFG. LTD.; building no 2 east park; shannon industrial estate; shannon, county clare ; EI
• Manufacturer Contact: christina arnt ; 56 e. bell dr.; warsaw, IN 46582 ; 5745273773
• MDR Report Key: 13206251
• Report Number: 3007963827-2022-00014
• Device Sequence Number: 4563907
• Product Code: JWH
• UDI-Device Identifier: 00889024240148
• UDI-Public: (01)00889024240148(17)271231(10)64461238
• Combination Product (Y/N): N
• Initial Reporter State: IN
• Initial Reporter Country: US
• PMA/510(K) Number: K172524
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2021
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,Distributor
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 04/26/2022

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: 42521200410
• Device Lot Number: 64461238
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/13/2021
• Supplement Date Received by Manufacturer: 04/25/2022
• Initial Report FDA Received Date: 01/10/2022
• Supplement Report FDA Received Date: 04/27/2022
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 12/18/2019
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• 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: Required Intervention; Hospitalization
• Patient Sex: Female
• Patient Weight: 99 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White