MAUDE Adverse Event Report: ZIMMER MANUFACTURING B.V. ALL-POLY PATELLA CEMENTED 38 MM DIAMETER; PROSTHESIS, KNEE

Model Number	42-5402-000-38
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Pain (1994); Swelling/ Edema (4577)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).Medical product: tibia cemented 5 degree stemmed right size g: catalog#42532007902, lot#64950764; articular surface medial congruent (mc) right 12 mm height use with tibia sizes g-h/cr femur sizes 8-11: catalog#42522100912, lot#64403887; femur cemented cruciate retaining (cr) standard right size 10: catalog#42502606802, lot#64824213; unknown bone cement: catalog#ni, lot#az46b10105.Multiple mdr reports have been filed for this event.Please see associated reports: 3007963827-2022-00318; 3007963827-2022-00319; 3007963827-2022-00320.The product will not be returned to zimmer biomet for evaluation as the product remains implanted.The investigation is in progress.Upon receipt of additional information or completion of the investigation, a follow-up mdr will be submitted.
Event or Problem Description
It was reported that a patient underwent an initial right total knee arthroplasty.The patient has subsequently experienced pain for over one year post-implantation.Infection has been ruled out and the medical team cannot determine what is causing the pain.The current outcome of the patient is unknown and further planned medical intervention has not been reported.Due diligence is in process for this event; to date no additional information has been reported.
Event or Problem Description
It was reported that a patient underwent an initial right total knee arthroplasty.Postoperatively, the patient did well until experiencing a fall approximately two months post-implantation.The patient hyperextended their knee and has subsequently experienced continued pain and swelling for over one year.The patient states he often feels unstable though the knee shows no signs of instability.Radiographically, the knee is stable and in anatomic position without complication.The patient's pain medications were increased and has been sent for a second orthopedic consultation.Further planned medical intervention has not been reported and the products remain implanted.All available information has been reported.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay additional information.The following sections have been updated: a1; a3; a4; b2; b4; b5; b7; d10; g3; h2; h3; h6; h10.D10: medical product: tibia cemented 5 degree stemmed right size g: catalog#42532007902, lot#64950764; articular surface medial congruent (mc) right 12 mm height use with tibia sizes g-h/cr femur sizes 8-11: catalog#42522100912, lot#64403887; femur cemented cruciate retaining (cr) standard right size 10: catalog#42502606802, lot#64824213; refobacin bc r 1x40 us: catalog#110034355, lot#az46bl0105.Visual and dimensional evaluations of the product could not be performed as no product was returned nor were pictures provided.Device history record was reviewed and no discrepancies related to the reported event were found.Medical records were provided and reviewed by a health care professional.Review of the available records identified the following: an initial right total knee arthroplasty was performed with no complications noted.Follow up office visits after the surgery reported the patient feeling pain with swelling and stiffness.Two months post op, the patient fell due to unknown reasons and the pain increased and continued up to the most recent provided office visit one year post implantation.There is currently no evidence of loosening and the patient has good stability and rom.Root cause was unable to be determined.It was noted the patient fell, but the reason for the fall is unknown.Additionally, the patient was experiencing pain before the fall occurred.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.

• Brand Name: ALL-POLY PATELLA CEMENTED 38 MM DIAMETER
• Common Device Name: PROSTHESIS, KNEE
• Manufacturer (Section D): ZIMMER MANUFACTURING B.V.; turpeaux industrial park; route #1 km 123.4 bldg #1; mercedita PR 00715
• Manufacturer (Section G): ZIMMER MANUFACTURING B.V.; turpeaux industrial park; route #1 km 123.4 bldg #1; mercedita PR 00715
• Manufacturer Contact: jennifer rapsavage ; 56 e. bell dr.; warsaw, IN 46582 ; 5745260384
• MDR Report Key: 15975744
• Report Number: 0002648920-2022-00248
• Device Sequence Number: 12502560
• Product Code: MBH
• UDI-Device Identifier: 00889024247710
• UDI-Public: (01)00889024247710(17)260716(10)65029458
• Combination Product (Y/N): N
• Initial Reporter State: IN
• Initial Reporter Country: US
• PMA/510(K) Number: K172524
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2021
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 01/25/2023

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 Expiration Date: 07/16/2026
• Device Model Number: 42-5402-000-38
• Device Catalogue Number: 42540200038
• Device Lot Number: 65029458
• 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: 11/22/2022
• Supplement Date Received by Manufacturer: 01/03/2023
• Initial Report FDA Received Date: 12/14/2022
• Supplement Report FDA Received Date: 01/25/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 08/25/2021
• 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
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: SEE H10 NARRATIVE.; SEE H10 NARRATIVE.
• Outcome Attributed to Adverse Event: Other; Required Intervention
• Patient Sex: Male
• Patient Weight: 108 KG