MAUDE Adverse Event Report: ZIMMER MANUFACTURING B.V. ALL POLY PATELLA STANDARD SIZE 35 MM DIAMETER 9.0 MM THICKNESS CEMENTED; PROSTHESIS, KNEE

Model Number	N/A
Medical Device Problem Codes	Loss of or Failure to Bond (1068); Loosening of Implant Not Related to Bone-Ingrowth (4002)
Health Effect - Clinical Codes	Pain (1994); Swelling (2091)
Date of Event	01/12/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).Multiple mdr reports were filed for this event, please see associated report: 0001822565-2021-00192.Medical product: femoral component option for cemented use only size d right item# 00588001402 lot# 64230855.Report source - (b)(6).The product has been returned to zimmer biomet for investigation.The investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.
Event or Problem Description
It was reported that a patient was revised approximately one year and three months post implantation due to pain and loosening of the femoral and patellar components.During the revision, it was noted that the hinge screw was cold-welded with adjacent necrosis on the medial femoral condyle.The tibial components were left in place, and all other components were revised without complication.
Event or Problem Description
No further event information available at the time of this report.
Additional Manufacturer Narrative
No product was returned or pictures provided; therefore, visual and dimensional evaluations could not be performed.Medical records/radiographs were provided and reviewed by a health care professional.Review of the available records identified the following: images were not sent for further review due to poor quality; patient presented with pain and signs of aseptic loosening of the femoral and patellar implant; very large intra-articular effusion noted, synovasure of fluid tested negative; "attempt to remove the hinge screw.This one is cold welded on the hinge."; necrosis of the internal femoral condyle and bone defects noted; femoral implant removed without difficulty; no sign of loosening or osteolysis of the tibia, left intact; new patella and femoral components placed without further complication.Device history record (dhr) was reviewed for deviations and/ or anomalies with no deviations / anomalies identified.A definitive root cause cannot be determined.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: ALL POLY PATELLA STANDARD SIZE 35 MM DIAMETER 9.0 MM THICKNESS CEMENTED
• 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: 11222342
• Report Number: 0002648920-2021-00016
• Device Sequence Number: 3803749
• Product Code: JWH
• UDI-Device Identifier: 00889024215153
• UDI-Public: (01)00889024215153
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• PMA/510(K) Number: K173057
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2019
• Device Explanted Year: 2021
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 04/16/2021

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: 00597206535
• Device Lot Number: 64325356
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 01/15/2021
• Supplement Date Received by Manufacturer: 05/15/2021
• Initial Report FDA Received Date: 01/25/2021
• Supplement Report FDA Received Date: 04/16/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• 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