MAUDE Adverse Event Report: ZIMMER BIOMET, INC. FEMUR CEMENTED PLUS RIGHT SIZE 9+; PROSTHESIS, KNEE

Model Number	N/A
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Muscular Rigidity (1968)
Date of Event	03/22/2023
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).Concomitant medical products: 42522600710 - articular surface fixed bearing constrained posterior stabilized (cps) right 10 mm height use with tibia sizes e-f / ps femur sizes 6-9 - 64781764.42540200029 - all-poly patella cemented 29 mm diameter - 65177526.42583103014 - stubby stem provisional 14 mm diameter 30 mm length - unknown.42532007102 - tibia cemented 5 degree stemmed right size e - 65284621.Reporting source: foreign country: australia.Customer has indicated that the product will not be returned to zimmer biomet for investigation.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: 3007963827-2023-00083, 0002648920-2023-00072, 0001822565-2023-00977.
Event or Problem Description
It was reported that the patient underwent a right knee surgery.Subsequently, the patient was revised approximately 7 months later due to stiffness.It was also discovered at the time of the revision via x-ray that the stem trial had remained implanted.The stem trial was removed and all implants were revised.Attempts have been made and no further information has been provided.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay additional information.The following sections were h6: suggested component code: mechanical (g04) - femur reported event was confirmed by review of medical records provided.Device was not returned.Device history record (dhr) was reviewed and no discrepancies relevant to the reported event were found.The root cause of the reported event is attributed to user does not follow instructions.Medical records and x-rays review indicates there is malposition of the femoral stem, bone quality is osteopenic, no radiolucency, loosening, or other abnormality, and the trail stem implanted.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.
Event or Problem Description
No further event information available at the time of this report.

• Brand Name: FEMUR CEMENTED PLUS RIGHT SIZE 9+
• Common Device Name: PROSTHESIS, KNEE
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 1800 w. center st.; warsaw IN 46580
• Manufacturer (Section G): ZIMMER BIOMET, INC.; 1800 w. center st.; warsaw IN 46580
• Manufacturer Contact: jennifer rapsavage ; 56 e. bell dr.; warsaw, IN 46582 ; 5745260384
• MDR Report Key: 16724667
• Report Number: 0001822565-2023-00976
• Device Sequence Number: 7292905
• Product Code: JWH
• UDI-Device Identifier: 00889024562721
• UDI-Public: (01)00889024562721(17)310222(10)64900887
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• PMA/510(K) Number: K191625
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2022
• Device Explanted Year: 2023
• 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): 07/14/2023

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: 42504606612
• Device Lot Number: 64900887
• 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: 03/22/2023
• Supplement Date Received by Manufacturer: 07/13/2023
• Initial Report FDA Received Date: 04/12/2023
• Supplement Report FDA Received Date: 07/14/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 03/01/2021
• 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
• Patient Weight: 77 KG