MAUDE Adverse Event Report: ZIMMER TMT TRABECULAR METAL TIBIAL CONE, MEDIUM 31X31MM; PROSTHESIS, KNEE

Model Number	N/A
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Hypersensitivity/Allergic reaction (1907); Pain (1994); Swelling (2091)
Date of Event	03/20/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).Report source: foreign (b)(6).Additional associated devices: item# 00545001830 lot# 64149178 trabecular metal femoral diaphyseal cone, 30mm, medium, left.Mdr 3005751028-2020-00067.
Event or Problem Description
It was reported that the patient had a total knee arthroplasty and subsequently the patient has stated that her knee has long been swollen and painful.The patient asks for information on the composition of the material of implants in order to understand if there is an allergic problem and perform a targeted test.
Additional Manufacturer Narrative
No product was returned; visual and dimensional evaluations could not be performed.Materials composition was provided.See dl1336709.Review of the device history record(s) identified no deviations or anomalies during manufacturing for item/lot (00545001830/64149178).The device history records for item/lot (00545001331/64226872) were reviewed for deviations and/or anomalies with the following related anomalies/deviations identified: one piece scrapped at operation 840.Review of complaint history found no additional related issues for this item and the reported part and lot combination (00545001830/64149178).Review of complaint history found no additional related issues for this item and the reported part and lot combination (00545001331/64226872).The reported products were reviewed for compatibility with no issues noted.Medical records were not provided.A field action search using cognos bi identified no quality hold with an r-code as the reason associated with the following part/lot (00545001830/64149178), (00545001331/64226872) combination as of (b)(6) 2020.A definitive root cause cannot be determined.The complaint is not confirmed.No corrective actions, preventive actions, or field actions resulted after investigation of this event.
Event or Problem Description
No further event information available at the time of this report.

• Brand Name: TRABECULAR METAL TIBIAL CONE, MEDIUM 31X31MM
• Common Device Name: PROSTHESIS, KNEE
• Manufacturer (Section D): ZIMMER TMT; 10 pomeroy road; parsippany NJ 07054
• MDR Report Key: 10295458
• Report Number: 3005751028-2020-00069
• Device Sequence Number: 2602975
• Product Code: JWH
• UDI-Device Identifier: 00889024308404
• UDI-Public: (01)00889024308404
• Combination Product (Y/N): N
• Initial Reporter Country: IT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2019
• Reporter Type: Manufacturer
• Report Source: company representative,distri
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 12/16/2020

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 Expiration Date: 01/31/2024
• Device Model Number: N/A
• Device Catalogue Number: 00545001331
• Device Lot Number: 64226872
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 06/29/2020
• Supplement Date Received by Manufacturer: 12/15/2020
• Initial Report FDA Received Date: 07/20/2020
• Supplement Report FDA Received Date: 12/16/2020
• 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: Required Intervention