MAUDE Adverse Event Report: ZIMMER BIOMET, INC. TIBIA FIXED CEMENTED RIGHT SIZE D STEM EXTENSION USE REQUIRED; PROSTHESIS, KNEE

Model Number	N/A
Medical Device Problem Code	Migration (4003)
Health Effect - Clinical Codes	Fall (1848); Pain (1994)
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that the patient underwent a revision surgery.Subsequently, the patient fell and reports ongoing pain.Attempts have been made and no further information has been provided.
Additional Manufacturer Narrative
(b)(4).The device will not be returned for analysis because it remains implanted; however, an investigation of the reported event is in progress.Once the investigation is completed, a supplemental medwatch will be submitted.Multiple mdr reports were filed for this event, please see associated reports: 0001822565-2022-01590, 0001822565-2022-01591, 0001822565-2022-01592, 0001822565-2022-01593, 0001822565-2022-01594, 0001822565-2022-01595.
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; h6; h10 no product was returned or pictures provided; visual and dimensional evaluations could not be performed.The device history record was reviewed and no discrepancies relevant to the reported event were found.The reported products were reviewed for compatibility and it was determined that the following implants are not compatible: competitor patella medical records were provided and reviewed by a health care professional.Review of the available records identified the following: (b)(6) 2022 patient presents with increased diffuse pain with all weightbearing activities, this has worsened in the past few months, she does not have instability or buckling but feels this limits her daily activities (b)(6) 2022 pain continues to limit the patient¿s day-to-day activities; (b)(6) 2022 pain is 8/10- deep pressure, tight, spasm, burning, ache, located intrapatellarly, worse with walking, improves with ice and rest; (b)(6) 2022 ct imaging reviewed demonstrates mild excess external rotation positioning of tibial component of a few degrees, moderate size knee joint effusion, fatty atrophy versus radiographs were provided and reviewed by a health care professional.Review of the available records identified the following: overall implant fit and alignment appear maintained.Bone quality appears osteopenic.Alignment is maintained despite the suspected tibial implant change in position as noted.A portion of the tibial implant appears proud (displaced cranially) in relation to the tibial implant base on the newer images.A definitive root cause cannot be determined.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
No further event information available at the time of this report.

• Brand Name: TIBIA FIXED CEMENTED RIGHT SIZE D STEM EXTENSION USE REQUIRED
• 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: 14516294
• Report Number: 0001822565-2022-01596
• Device Sequence Number: 20241271
• Product Code: JWH
• UDI-Device Identifier: 00889024562875
• UDI-Public: (01)00889024562875(17)290331(10)64315016
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: K181947
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2020
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Consumer,Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 10/24/2022

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: 42542006702
• Device Lot Number: 64315016
• 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: 05/09/2022
• Supplement Date Received by Manufacturer: 10/21/2022
• Initial Report FDA Received Date: 05/26/2022
• Supplement Report FDA Received Date: 10/24/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 03/22/2019
• 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
• 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: Other
• Patient Sex: Female
• Patient Weight: 88 KG