MAUDE Adverse Event Report: Zimmer Surgical, Inc. Disposable Mixing Bowl And Spatula; Mixer, Cement, For Clinical Use

Catalog Number	00504901100
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Medical device site infection (4845)
Date of Event	02/03/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that the patient underwent an initial knee procedure.A washout and liner exchange occurred approximately five and a half months post-implantation due to suspected prosthetic joint infection following a positive synovasure test.Attempts have been made and no further information has been provided.
Event or Problem Description
No further information at the time of this report.
Additional Manufacturer Narrative
(b)(4).D10: cat# 2009127agc lot# 467189 zim osc 20x90x1.27 cgts.Cat# 5122145 lot# 73761516 palacos r+g x 40gms.Cat# 00-5901-020-00 lot# 67193699 3.2mm x 75mm trocar tip drill pin 4 pk.Cat# 42-5026-056-01 lot# 65515413 psn fem cr cmt ccr std sz 4 l.Cat# 43-5320-067-01 lot# 67550926 psn tib np stem 5 deg sz d l.Cat# 42-5120-004-13 lot# 66679665 psn asf cr 13mm ve l 3-9 cd.G2: foreign - event occurred in singapore.The device will not be returned for analysis; however, an investigation of the reported event is in progress.Once the investigation is completed, a supplemental medwatch 3500a will be submitted.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay additional information.The following sections were {update/corrected} updated: d4; g3; h2; h3; h4; h6 no product was returned or pictures provided; visual and dimensional evaluations could not be performed.The provided picture shows the positive synovasure test kit result.Review of the device history records identified no deviations or anomalies during manufacturing.Medical records were not provided.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: Disposable Mixing Bowl And Spatula
• Common Device Name: Mixer, Cement, For Clinical Use
• Manufacturer (Section D): Zimmer Surgical, Inc.; 200 west ohio avenue; dover OH 44622
• Manufacturer (Section G): Zimmer Surgical, Inc.; 200 west ohio avenue; dover OH 44622
• Manufacturer Contact: jennifer rapsavage ; 56 e. bell drive; warsaw, IN 46582 ; +1(574)526-0384
• MDR Report Key: 50454180
• Report Number: 0001526350-2026-01042
• Device Sequence Number: 21442818
• Product Code: JDZ
• UDI-Device Identifier: 00889024376564
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 09/28/2026

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 Catalogue Number: 00504901100
• Device Lot Number: 85390028
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/30/2026
• Supplement Date Received by Manufacturer: 09/23/2026
• Initial Report FDA Received Date: 08/26/2026
• Supplement Report FDA Received Date: 09/28/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/22/2025
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: See H11 Narrative.
• Outcome Attributed to Adverse Event: Required Intervention; Hospitalization
• Patient Sex: Unknown