MAUDE Adverse Event Report: ZIMMER BIOMET, INC. REGENEREX SERIES A PATELLA 3 PEG DCM ARCOM POROUS TITANIUM; PROSTHESIS, KNEE

Model Number	N/A
Medical Device Problem Codes	Corroded (1131); Fracture (1260); Material Fragmentation (1261)
Health Effect - Clinical Codes	Failure of Implant (1924); Pain (1994); Synovitis (2094); Discomfort (2330); Metal Related Pathology (4530); Swelling/ Edema (4577)
Date of Event	12/20/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Customer has indicated that the product will not be returned to zimmer biomet for investigation as the hospital policy will not allow returns.The investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.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.
Event or Problem Description
It was reported that a patient underwent an initial knee procedure.Subsequently, the patient was revised two years later due to discomfort and pain.Titanium pegs on backside of patellar component sheared off during use.The plastic patellar component as well as the sheared off metal debris were removed.
Event or Problem Description
No further event information available at the time of this report.
Additional Manufacturer Narrative
(b)(4).Reported event was unable to be confirmed due to limited information received from the customer.No devices or photos were received; therefore, the condition of the components is unknown.Review of the device history record identified no deviations or anomalies during manufacturing.No medical records were provided.The root cause of the patella peg fracture was determined to be a labeling and training deficiency as the surgical technique addendum for installation of regenerex patella failed to include guidance on depth line indication on the peg drill bit.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.
Event or Problem Description
It was reported that the patient underwent an initial knee arthroplasty.Approximately 2 years post implantation, the patient was revised due to pain and discomfort.During the revision, it was noted the patella peg had sheared off and was freely floating within the knee, metal debris, metallosis, synovitis, and gray tissue.The patella was revised.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay additional information.D10: 141273 - tibial component - 865310, 141369 - stem - 588030, ep-183641 - tibial insert - 464080, 184506 - femoral component - 009280.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.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay additional information.No devices or photos were received; therefore, the condition of the components is unknown.The device history record was reviewed and no discrepancies relevant to the reported event were found.Primary operative notes state no intra- operative complication.Revision surgical notes confirm that document provided state that patella component had sheared off at its pegs and was freely floating within the knee.Noted metal debris, gray tissue throughout the knee, patella sheared off at its pegs and was freely floating within the knee.Performed synovectomy of medial and lateral gutters, intercondylar notch, and removed patella component.The root cause of the patella peg fracture was determined to be a labeling and training deficiency as the surgical technique addendum for installation of regenerex patella failed to include guidance on depth line indication on the peg drill bit.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: REGENEREX SERIES A PATELLA 3 PEG DCM ARCOM POROUS TITANIUM
• Common Device Name: PROSTHESIS, KNEE
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 56 e. bell drive; warsaw IN 46582
• Manufacturer (Section G): ZIMMER BIOMET, INC.; 56 e. bell drive; warsaw IN 46582
• Manufacturer Contact: christina arnt ; 56 e. bell dr.; warsaw, IN 46582 ; 5745273773
• MDR Report Key: 8577769
• Report Number: 0001825034-2019-01969
• Device Sequence Number: 16528306
• Product Code: JWH
• UDI-Device Identifier: 00880304554405
• UDI-Public: (01)00880304554405(17)210307(10)006170
• Combination Product (Y/N): N
• Initial Reporter State: ND
• Initial Reporter Country: US
• PMA/510(K) Number: K171054
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2016
• Device Explanted Year: 2018
• 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): 08/29/2022

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 Expiration Date: 03/07/2021
• Device Model Number: N/A
• Device Catalogue Number: 141355
• Device Lot Number: 006170
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 04/08/2019
• Supplement Date Received by Manufacturer: 10/09/2019; 04/14/2022; 08/29/2022
• Initial Report FDA Received Date: 05/03/2019
• Supplement Report FDA Received Date: 10/11/2019; 05/06/2022; 08/30/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 03/07/2016
• 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
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention
• Patient Age: 70 YR
• Patient Sex: Female
• Patient Weight: 68 KG