MAUDE Adverse Event Report: ZIMMER MANUFACTURING B.V. ALL POLY PATELLA CEMENTED 32 MM DIAMETER; PROSTHESIS, KNEE

Model Number	N/A
Medical Device Problem Code	Unstable (1667)
Health Effect - Clinical Codes	Inflammation (1932); Pain (1994); Swelling (2091); Patient Problem/Medical Problem (2688)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).Customer has indicated that the product will not be returned to zimmer biomet for investigation, as the device remains implanted.The investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.Implant date: (b)(6) 2018.Concomitant medical products: 42522400714, articular surface, lot # 62957509 , 42500006402, femur cemented, lot # 63239724, 42532007102, tibia cemented, lot # 63295727.Multiple mdr reports were filed for this event, please see associated reports: 0001822565 - 2019 - 04627, 3007963827 - 2019 - 00305, 0002648920 - 2019 - 00780.
Event or Problem Description
It was reported that approximately 17 months post implantation, the patient has been experiencing pain, swelling, and instability.Attempts have been made and no further information has been provided.
Event or Problem Description
It was reported that approximately 3 years post implantation, the patient has been experiencing pain, swelling, and instability.Attempts have been made and no further information has been provided.
Additional Manufacturer Narrative
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.Concomitant medical products: 00111214001, bone cement, lot # 82564431 (qty: 2).Multiple mdr reports were filed for this event, please see associated reports: 0001822565 - 2019 - 05301, 0001822565 - 2019 - 05303.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay additional information.No devices were received; therefore the condition of the components is unknown.The dhr was reviewed and no discrepancies relevant to the reported event were found.Primary operative notes does not suggest any intra operative complications.Office notes state that patient consistently complained about pain, stiffness, range of motion.X-ray shows implants in good position without complications.Patient presented with pain and moderate swelling of bilateral knees, stiffness and antalgic gait with a walker.Office notes state that patient has consistent knee pain 9/10 (severe) as well as consistent low back pain right side greater than left, no instability, tenderness to palpation over the medial and lateral joint lines of the left knee.Mri results state - mild to moderate degenerative changes combined with excess epidural fat in the lower lumbar spine result in areas of spinal canal narrowing, l3-s1 mild to moderate spinal canal stenosis, disc bulge.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: ALL POLY PATELLA CEMENTED 32 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
• MDR Report Key: 9252144
• Report Number: 0002648920-2019-00781
• Device Sequence Number: 2363242
• Product Code: JWH
• UDI-Device Identifier: 00889024247635
• UDI-Public: (01)00889024247635
• Combination Product (Y/N): N
• Initial Reporter State: MO
• Initial Reporter Country: US
• PMA/510(K) Number: K113369
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2016
• Reporter Type: Manufacturer
• Report Source: consumer
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 04/09/2020

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: 03/31/2024
• Device Model Number: N/A
• Device Catalogue Number: 42540000032
• Device Lot Number: 63314563
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 10/14/2019
• Supplement Date Received by Manufacturer: 11/26/2019; 04/07/2020
• Initial Report FDA Received Date: 10/29/2019
• Supplement Report FDA Received Date: 12/16/2019; 04/09/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Weight: 136