MAUDE Adverse Event Report: ZIMMER BIOMET, INC. RGX 3 PEG SER A PATELLA 34MM; PROSTHESIS-KNEE

Model Number N/A

Device Problems Fracture (1260); Defective Device (2588); Insufficient Information (3190)

Patient Problems Injury (2348); Reaction (2414); No Information (3190)

Event Date 08/28/2018

Event Type  Injury  

Manufacturer Narrative

(b)(4).Multiple mdr reports were filed for this event, please see associated report: 0001825034-2018-08869, 0001825034-2018-08870, 0001825034-2018-08871, 0001825034-2018-08872.(b)(4).Concomitant medical products: e1 vngd ps tib brg 79/83x10 item# ep-183660 lot# 534320.Bmet regenx pri tib tray 79mm item# 141275 lot# 360260.Biomet finned pri stem 40mm item# 141314 lot# 539880.Vngd ps open por fmrl lt 67.5 item# 184530 lot# 100060.Customer has not indicated that 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 Description

It was reported that patient underwent initial left knee procedure and subsequently underwent a revision for an unknown reason.No additional information is available at this time.

Event Description

It was reported that this patient did have the patella revised.No further information is available at this time.

Manufacturer Narrative

This follow-up is being submitted to relay additional information.Review of the primary operative notes state that patient had severe osteoarthritis of left knee.There were noted to be a lot of osteophytes - a bony outgrowth associated with the degeneration of cartilage at joints - in the patella.There were no other intraoperative complications.No devices were received, therefore the condition of the components is unknown.Dhr was reviewed and no discrepancies were found.As the reason for the revision is unknown, a root cause cannot be determined.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.

Manufacturer Narrative

The reported event was confirmed by review of medical records.Review of the primary operative notes state that patient had severe osteoarthritis of left knee.There were noted to be a lot of osteophytes - a bony outgrowth associated with the degeneration of cartilage at joints - in the patella.There were no other intraoperative complications.Review of the revision operative notes noted that the patient presented with pain and swelling and radiographs confirmed the patella implant had fractured.It was noted intraoperatively, that there was a lot of fluid in the joint and the synovium was blackened due to metallosis.An incompatible competitor patella was implanted in the revision.No devices were received; therefore, the condition of the components is unknown.Device history record (dhr) was reviewed for deviations and/ or anomalies with no related deviations / anomalies identified.The root cause of the increased rate of 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.However, it is unknown if this is what resulted in the reported event.A definitive root cause cannot be determined.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 is being submitted to relay additional information.

Event Description

It was reported that a patient underwent an initial left knee procedure and subsequently the patient was revised due to a fractured patella button and metallosis.

Manufacturer Narrative

This follow-up is being submitted to relay additional information.Visual examination of the returned device found signs of being implanted wear/discoloration / foreign material.All three of the posts have fractured off.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.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.

• Brand Name: RGX 3 PEG SER A PATELLA 34MM
• Type of Device: PROSTHESIS-KNEE
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 56 e. bell drive; warsaw IN 46582
• MDR Report Key: 7893047
• MDR Text Key: 120829396
• Report Number: 0001825034-2018-08868
• Device Sequence Number: 1
• Product Code: MBH
• Combination Product (y/n): N
• PMA/PMN Number: PK083782
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer,health professional
• Type of Report: Initial,Followup,Followup,Followup,Followup
• Report Date: 10/12/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/20/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 08/01/2020
• Device Model Number: N/A
• Device Catalogue Number: 141357
• Device Lot Number: 328720
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/20/2021
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 10/07/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: N/A
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 73 YR