MAUDE Adverse Event Report: ZIMMER BIOMET, INC. BIOMET CC CRUCIATE TRAY; PROSTHESIS KNEE

Model Number	N/A
Medical Device Problem Codes	Adverse Event Without Identified Device or Use Problem (2993); Insufficient Device Problem Information (3190); Loosening of Implant Not Related to Bone-Ingrowth (4002)
Health Effect - Clinical Codes	Arthritis (1723); Failure of Implant (1924); Pain (1994); Loss of Range of Motion (2032); Ambulation or Postural Difficulties (2544); Joint Contracture (4528); Swelling/ Edema (4577); Insufficient Information (4580)
Date of Event	10/12/2021
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported patient underwent a revision procedure four years post implantation due to unknown reason in knee.Attempts to obtain additional information have been made; however, no more is available at this time.
Additional Manufacturer Narrative
(b)(4).D10 ¿ concomitant medical product: series a pat thn 34 3 peg catalog # 184786 lot # 361710.E1 vngd ps tib brg 71/75x12 catalog # ep-183642 lot # 772640.Vngd ps open intl fem rt 60 catalog # 183104 lot # j3882188.H3: customer has indicated that the product will not be returned because product location is unknown.The investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.Multiple mdr reports were filled for this event: 0001825034-2023-01750.0001825034-2023-01754.0001825034-2023-01755 h3 other text : product location unknown.
Event or Problem Description
Upon receipt of information received and reassessment of the reported event, it was determined to be not reportable.There is no issues with zimmer biomet device, as the event was the result of a patient condition.The initial report was forwarded in error and should be voided.
Additional Manufacturer Narrative
Upon receipt of information received and reassessment of the reported event, it was determined to be not reportable.There is no issues with zimmer biomet device, as the event was the result of a patient condition.The initial report was forwarded in error and should be voided.
Additional Manufacturer Narrative
This follow-up report is being filled to relay additional information, which was unknown at the time of the initial medwatch.D10 ¿ medical product: unk cement catalog # unk lot # unk.It was previously reported on mfr # 0001825034-2023-01753-1 that there is no issues with zimmer biomet device, as the event was the result of a patient condition.However, upon receipt of additional information, it is now verified that this device is related to the event.
Event or Problem Description
It was reported patient underwent a revision procedure four years post implantation due to tibial loosening.Attempts to obtain additional information have been made; however, no more is available.
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.Reported event was confirmed by review of x-rays provided.Device was not returned.Device history record (dhr) was reviewed and no discrepancies relevant to the reported event were found.A definitive root cause cannot be determined.X-ray review indicates there is loose tibial component, revised, removed cement, pain, swelling, stiffness, knee brace/assistive device, limitations with adls and clicking of knee.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: BIOMET CC CRUCIATE TRAY
• Common Device Name: PROSTHESIS KNEE
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 56 e. bell drive; p.o. box 587; warsaw IN 46581
• Manufacturer (Section G): ZIMMER BIOMET, INC.; 56 e. bell drive; p.o. box 587; warsaw IN 46581
• Manufacturer Contact: jennifer rapsavage ; 56 e. bell dr.; warsaw, IN 46582 ; 5745260384
• MDR Report Key: 17408417
• Report Number: 0001825034-2023-01753
• Device Sequence Number: 7357846
• Product Code: JWH
• UDI-Device Identifier: 00880304001466
• UDI-Public: (01)00880304001466(17)260721(10)J3842692
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: K171054
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2017
• Device Explanted Year: 2021
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,Distributor
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup,Followup
• Report Date (Section B): 11/21/2023

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?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 07/21/2026
• Device Model Number: N/A
• Device Catalogue Number: 141233
• Device Lot Number: J3842692
• 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: 07/07/2023
• Supplement Date Received by Manufacturer: 08/31/2023; 10/03/2023; 11/10/2023
• Initial Report FDA Received Date: 07/27/2023
• Supplement Report FDA Received Date: 09/06/2023; 10/18/2023; 11/21/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 07/21/2016
• 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
• Concomitant Medical Products and Therapy/Usage Dates: SEE H10 NARRATIVE.
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention
• Patient Sex: Female
• Patient Weight: 118 KG