MAUDE Adverse Event Report: ZIMMER BIOMET, INC. REGENEREX 3 PEG SERIES A PATELLA 31MM; PROSTHESIS, KNEE

Model Number	N/A
Medical Device Problem Codes	Fracture (1260); Patient Device Interaction Problem (4001)
Health Effect - Clinical Codes	Failure of Implant (1924); Pain (1994); Scar Tissue (2060)
Date of Event	02/23/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).Concomitant medical products: vanguard posterior stabilized porous femoral component right 65mm, catalog #: 184508, lot #: 110980; biomet regenerex primary tibial tray 71mm, catalog #: 141273, lot #: 288640; vanguard e1 posterior stabilized tibial bearing 10mm x 71/75mm, catalog #: ep-183640, lot #: 302330; biomet finned primary stem 40mm, catalog #: 141314, lot #: 623390.The complainant has not yet indicated whether the product will be 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 the patient underwent a right knee arthroplasty revision to address pain and patellar implant fracture approximately four (4) years post-operatively.Initial operative notes did not identify any intraoperative complications related to the implants.Revision operative notes noted that the patient had metallosis-blackened tissue and synovium.Additionally, the patella was noted to be loose, held in by scar tissue and all three (3) pegs had broken off.
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.The following sections were updated.The complaint sample was returned and visual examination of the product identified signs of being implanted such as wear, discoloration and foreign material and all three posts had fractured off.The root cause remains unchanged at this time.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
No further event information available at the time of this report.
Additional Manufacturer Narrative
Reported event was confirmed by review of medical records noting the patella pegs had broken and continued to have pain.Metallosis blackened tissue and synovium was noted.Patella was just loose and was held in by scar tissue all 3 pegs had broken off.Dhr was reviewed and no discrepancies were found.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.

• Brand Name: REGENEREX 3 PEG SERIES A PATELLA 31MM
• 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: 11692385
• Report Number: 0001825034-2021-01123
• Device Sequence Number: 2980758
• Product Code: JWH
• UDI-Device Identifier: 00880304554412
• UDI-Public: (01)00880304554412(17)211207(10)561750
• Combination Product (Y/N): N
• Initial Reporter State: GA
• 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: Consumer,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 03/16/2022

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: 12/07/2021
• Device Model Number: N/A
• Device Catalogue Number: 141356
• Device Lot Number: 561750
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 03/31/2021
• Supplement Date Received by Manufacturer: 05/27/2021; 03/09/2022
• Initial Report FDA Received Date: 04/20/2021
• Supplement Report FDA Received Date: 05/28/2021; 03/17/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 12/07/2016
• 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
• Concomitant Medical Products and Therapy/Usage Dates: SEE H10 NARRATIVE
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention
• Patient Sex: Female