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

Model Number	N/A
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Codes	Necrosis (1971); Pain (1994); Metal Related Pathology (4530)
Date of Event	06/29/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).Medical product: catalog # 141356, regenerex 3 peg series a patella dcm arcom porous titanium lot # 561780.Catalog #: 184512, vngd ps open por fmrl rt 70, lot # 421160.Catalog #: 141316, biomet finned pri stem 80x10mm, lot # 980570.Catalog #: 141274, bmet regenx pri tib tray 75mm, lot # 504580.Catalog # ep-183740; e1 vngd ps+ tib brg 71/75x10, lot # 403580.Customer has indicated that the product will not be returned because product location is unknown.Multiple mdr reports were filled for this event: 0001825034-2019-01920.0001825034-2020-04294.Reported event was considered confirmed from x-rays showing the patella component fractured.Device not returned.Device history record was reviewed and no discrepancies relevant to the reported event 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.Root cause cannot be determined for bearing and tibial tray.X-ray review indicates that the patella component fractured and there is patellar component radiolucency.Other than that there was normal alignment and reveals no joint space narrowing.Revision operative notes confirm that the tibial component was broken into 3 pieces.After removal of pin, poly came out in 3 pieces.Femoral component was found intact.Metallosis, necrotic tissue and bone were seen with blackened tissue.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 right knee procedure approximately two years ago.Subsequently, the patient suffered pain in the knee joints and has a fractured patella.Further it was reported that the patient was revised due pain, implant fracture, metallosis, necrotic tissue and bone.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay additional information.H6: type of investigation - device not returned is n/a which was reported on initial report.Investigation conclusions - cause traced to intentional off-label, unapproved, or contraindicated use and cause traced to user is n/a which was reported on initial report.Visual evaluation of the returned device shows signs of being implanted wear/discoloration / foreign material and two of the three pegs have fractured.The root cause of the patella peg fracture was determined to be a labeling and training deficiency.Additional information does not affect the root cause for bearing and tibial tray.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.

• Brand Name: RGX 3 PEG SER 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: 11709023
• Report Number: 0001825034-2021-01208
• Device Sequence Number: 3137670
• Product Code: JWH
• UDI-Device Identifier: 00880304554412
• UDI-Public: (01)00880304554412(17)211204(10)561780
• 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: 2020
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Consumer,Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 03/17/2022

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: 12/04/2021
• Device Model Number: N/A
• Device Catalogue Number: 141356
• Device Lot Number: 561780
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• 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: 04/20/2021
• Supplement Date Received by Manufacturer: 03/10/2022
• Initial Report FDA Received Date: 04/22/2021
• Supplement Report FDA Received Date: 03/17/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 12/04/2016
• 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