MAUDE Adverse Event Report: ZIMMER TMT TRABECULAR METAL DISTAL FEMORAL AUGMENT BLOCK; PROSTHESIS, KNEE

Model Number	N/A
Medical Device Problem Code	Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Serious Injury
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 & mdrs.Stem extension straight 15mm dia x 100mm length item# 00598801015 lot# 64303799 mdr: 0002648920-2022-00142.Femoral component size f left item# 00599401691 lot# 64263940 mdr: 0001822565-2022-01785.Articular surface 12 mm height item# 00596205112 lot# 63614053 mdr: 0001822565-2022-01786.Stem extension straight 15mm dia x 30mm length item# 00598801215 lot# 64394745 mdr: 0002648920-2022-00143.
Event or Problem Description
It was reported by 411 that a patient underwent a knee arthroplasty.Subsequently, 2 years 10 months post implantation, the patient is being considered for a revision on an unknown day for an unknown reason.The sales representative was requesting implant availability.
Event or Problem Description
No further event information available at the time of this report.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay additional information.No product was returned; visual and dimensional evaluations could not be performed.Review of the device history record(s) identified no deviations or anomalies during manufacturing.Review of the receiving inspection report(s) identified no deviations or anomalies during manufacturing.The reported products were reviewed for compatibility with no issues noted.Review of complaint history found no additional related issues for this item and the reported part and lot combination.Medical records were not provided.A definitive root cause cannot be determined.No corrective actions, preventive actions, or field actions resulted after investigation of this event.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: TRABECULAR METAL DISTAL FEMORAL AUGMENT BLOCK
• Common Device Name: PROSTHESIS, KNEE
• Manufacturer (Section D): ZIMMER TMT; 10 pomeroy road; parsippany NJ 07054
• Manufacturer (Section G): ZIMMER TMT; 10 pomeroy road; parsippany NJ 07054
• Manufacturer Contact: jennifer rapsavage ; 56 e. bell dr.; warsaw, IN 46582 ; 5745260384
• MDR Report Key: 14754159
• Report Number: 3005751028-2022-00018
• Device Sequence Number: 13790604
• Product Code: JWH
• UDI-Device Identifier: 00889024309616
• UDI-Public: (01)00889024309616(17)240229(10)64227736
• Combination Product (Y/N): N
• Initial Reporter State: AL
• Initial Reporter Country: US
• PMA/510(K) Number: K024161
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2019
• 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): 08/11/2022

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 Expiration Date: 02/29/2024
• Device Model Number: N/A
• Device Catalogue Number: 00549003620
• Device Lot Number: 64227736
• Was Device Available for Evaluation?: No
• 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: 05/23/2022
• Supplement Date Received by Manufacturer: 08/09/2022
• Initial Report FDA Received Date: 06/21/2022
• Supplement Report FDA Received Date: 08/17/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 02/08/2019
• 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
• 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: Other
• Patient Age: 76 YR
• Patient Sex: Male