MAUDE Adverse Event Report: ZIMMER BIOMET, INC. REGENEREX 3 PEG SER A PATELLA 28MM; PROSTHESIS, KNEE

Model Number	N/A
Medical Device Problem Codes	Fracture (1260); Loosening of Implant Not Related to Bone-Ingrowth (4002)
Health Effect - Clinical Codes	Failure of Implant (1924); Pain (1994)
Date of Event	03/24/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).Concomitant devices -vngd ps open por fmrl lt 62.5, catalog #: 184526, lot #: 993610; e1 vngd ps+ tib brg 63/67x10, catalog #: ep-183720, lot #: 315430; biomet finned pri stem 80x10mm, catalog #: 141316, lot #: 486030; bmet regenx pri tib tray 67mm, catalog #: 141272, lot #: 060430.The complainant has indicated that the product will not be returned to zimmer biomet for investigation, as the device remains implanted.The results of the investigation are as follows: no devices or photos were received; therefore, the condition of the components is unknown.Review of the device history record identified no related deviations or anomalies during manufacturing.Primary operative notes does not suggest any intra operative complications.Office visit notes from the doctor states that x-ray report revealed that all three patella pegs are broken causing loose patella and pain.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.A corrective action has been initiated to address the malfunction.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 a patient received a left total knee arthroplasty.During an office visit it was noted the patients patella has failed.All 3 pegs are off and the looseness of patella is causing her pain.Patient has not underwent a revision procedure to date.

• Brand Name: REGENEREX 3 PEG SER A PATELLA 28MM
• Common Device Name: PROSTHESIS, KNEE
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 56 e. bell drive; warsaw IN 46582
• MDR Report Key: 12214165
• Report Number: 0001822565-2021-01953
• Device Sequence Number: 17241404
• Product Code: OIY
• UDI-Device Identifier: 00880304554405
• UDI-Public: (01)00880304554405(17)211204(10)619490
• 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
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,consum
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 07/22/2021

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 Expiration Date: 12/04/2021
• Device Model Number: N/A
• Device Catalogue Number: 141355
• Device Lot Number: 619490
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/25/2021
• Initial Report FDA Received Date: 07/22/2021
• 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: Z-2068-2017
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Age: 60 YR