MAUDE Adverse Event Report: ZIMMER BIOMET, INC. FEMUR TRABECULAR METAL CRUCIATE RETAINING (CR); PROSTHESIS, KNEE

Model Number	N/A
Medical Device Problem Code	Device Dislodged or Dislocated (2923)
Health Effect - Clinical Code	Joint Dislocation (2374)
Date of Event	04/29/2022
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that the patient underwent an initial total knee arthroplasty.Subsequently, the implanted articular surface dislocated postoperatively and the patient underwent a revision procedure to replace the dislocated implant approximately 23 days later.Attempts have been made and no further information has been provided.
Additional Manufacturer Narrative
(b)(4).Concomitant medical products: 42522100410 - articular surface medial congruent (mc) right 10 mm height use with tibia sizes c-d/cr femur sizes 6-7 - 65280730.42532006702 - tibia cemented 5 degree stemmed right size d - 65283312.Report source: foreign country: (b)(6).Customer has indicated that the product will not be returned to zimmer biomet for investigation, as it remains implanted.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: 3007963827-2022-00135.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay additional information.The following sections were updated: b4; b5; g3; g6; h1; h2; h3 upon receipt of additional information, it has been determined this zimmer biomet device did not cause or contribute to the reported event.The initial report was forwarded in error and should be voided.If any further information is found which would change or alter any conclusions or information, a supplemental report will be filed accordingly.Zimmer biomet will continue to monitor for trends.
Event or Problem Description
Upon receipt of additional information, it has been determined this zimmer biomet device did not cause or contribute to the reported event.The initial report was forwarded in error and should be voided.

• Brand Name: FEMUR TRABECULAR METAL CRUCIATE RETAINING (CR)
• Common Device Name: PROSTHESIS, KNEE
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 56 e. bell drive; warsaw IN 46582
• Manufacturer (Section G): ZIMMER BIOMET, INC.; 56 e. bell drive; warsaw IN 46582
• Manufacturer Contact: christina arnt ; 56 e. bell dr.; warsaw, IN 46582 ; 5745273773
• MDR Report Key: 14455378
• Report Number: 0001822565-2022-01515
• Device Sequence Number: 6340453
• Product Code: MBH
• UDI-Device Identifier: 00889024470088
• UDI-Public: (01)00889024470088(17)311201(10)65101124
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K172524
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2022
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 06/14/2022

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?: Yes
• Operator of Device: Health Professional
• Device Model Number: N/A
• Device Catalogue Number: 42502206202
• Device Lot Number: 65101124
• 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: 04/29/2022
• Supplement Date Received by Manufacturer: 06/14/2022
• Initial Report FDA Received Date: 05/20/2022
• Supplement Report FDA Received Date: 06/16/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 12/08/2021
• 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: Hospitalization; Required Intervention
• Patient Sex: Female