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

Model Number	N/A
Medical Device Problem Codes	Loss of or Failure to Bond (1068); Fracture (1260); Loosening of Implant Not Related to Bone-Ingrowth (4002)
Health Effect - Clinical Codes	Failure of Implant (1924); Pain (1994); Scar Tissue (2060); Joint Laxity (4526)
Date of Event	11/16/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).Medical product vngd ps open por fmrl rt 67.5 item# 184510 lot# 494730; bmet regenx pri tib tray 71mm item# 141273 lot# 360190; biomet finned pri stem 40mm item# 141314 lot# 943150; rgx 3 peg ser a patella 31mm item# 141356 lot# 870260; e1 vngd ps+ tib brg 71/75x14 item# ep-183744 lot# 575950.Customer has indicated that the product will not 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 a patient underwent a right knee revision procedure approximately five years¿ post-implantation due to pain, implant fracture, scar tissue, and loosening.There is no additional information available at this time.
Additional Manufacturer Narrative
(b)(4).Reported event was confirmed per the medical records which found a broken patella component causing pain.A fibroma was excised.A lot of scar tissue was found beneath the patella.The patella was found loose and when removed all 3-pegs were found broken off and remained in the patella.Device history record was reviewed and no discrepancies relevant to the reported event were found.The root cause of the event 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.This event was farther investigated through the capa process.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.
Event or Problem Description
It was further reported that the patient had a right total knee arthroplasty.Subsequently, two years post-op, the patient fell and began to have stiffness and pain in the patella region.The patient reported that the knee was giving out and the patient continued with pain until they were subsequently revised 5 years post-op.During the revision, a fibroma was excised, extensive scar tissue beneath the patella was encountered, the patella was loose, and three pegs of the patella were found fractured.All available information has been provided.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay additional information.The following sections were updated: b4; b5; b6; d2; g1; g3; g6; h1; h2; h6.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.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay additional information.The following sections were updated: b4; b5; d2; g1; g3; g6; h1; h2; h6.Additional medical records were provided.Notes reported stiffness and pain coming from patella after a fall.X-ray was taken and did not show abnormalities.Office visit notes states that patient's knee continued giving pain and giving out and was treated with steroid injections.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.

• Brand Name: RGX 3 PEG SER A PATELLA 31MM
• Common Device Name: PROSHTESIS, 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: 11464660
• Report Number: 0001825034-2021-00732
• Device Sequence Number: 3191453
• Product Code: MBH
• UDI-Device Identifier: 00880304554412
• UDI-Public: (01)00880304554412(17)200901(10)870260
• Combination Product (Y/N): N
• Initial Reporter State: GA
• Initial Reporter Country: US
• PMA/510(K) Number: K083782
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2015
• Device Explanted Year: 2020
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Consumer,Health Professional,Company Representative,Distributor
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup,Followup
• Report Date (Section B): 09/15/2023

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: 09/01/2020
• Device Model Number: N/A
• Device Catalogue Number: 141356
• Device Lot Number: 870260
• 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: 02/18/2021
• Supplement Date Received by Manufacturer: 04/09/2021; 08/15/2023; 09/15/2023
• Initial Report FDA Received Date: 03/11/2021
• Supplement Report FDA Received Date: 04/09/2021; 09/11/2023; 09/15/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 09/01/2015
• 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
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention
• Patient Age: 49 YR
• Patient Sex: Female
• Patient Weight: 159 KG