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

Model Number N/A

Device Problems Loss of or Failure to Bond (1068); Fracture (1260); Loosening of Implant Not Related to Bone-Ingrowth (4002)

Patient Problems Failure of Implant (1924); Pain (1994); Scar Tissue (2060); Joint Laxity (4526)

Event Date 11/16/2020

Event Type  Injury  

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 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.

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 Description

No further event information available at the time of this report.

Event 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.

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.

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 Description

No further event information available at the time of this report.

• Brand Name: RGX 3 PEG SER A PATELLA 31MM
• Type of Device: 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
• MDR Text Key: 239392266
• Report Number: 0001825034-2021-00732
• Device Sequence Number: 1
• Product Code: MBH
• UDI-Device Identifier: 00880304554412
• UDI-Public: (01)00880304554412(17)200901(10)870260
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K083782
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Consumer,Health Professional,Company Representative,Distributor
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 09/15/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/11/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: 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
• Date Manufacturer Received: 09/15/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 09/01/2015
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Removal/Correction Number: N/A
• Patient Sequence Number: 1
• Treatment: SEE H10
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 49 YR
• Patient Sex: Female
• Patient Weight: 159 KG