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

Model Number N/A

Device Problem Fracture (1260)

Patient Problems Adhesion(s) (1695); Pain (1994)

Event Date 08/27/2019

Event Type  Injury  

Manufacturer Narrative

(b)(4).Concomitants medical products: rgx 3 peg ser a patella 34mm; p/n: 141357, l/n: 952030.Vngd ps open por fmrl lt 75; p/n: 184534, l/n: 763350.E1 vngd ps tib brg 79/83x10 x 10; p/n: ep-183660, l/n: 810930.Bmet regenx pri tib tray 83mm cocr 83mm; p/n: 141276, l/n: 728280.Biomet finned pri stem 40mm; p/n: 141314, l/n: 976290.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.Product location is unknown.

Event Description

It was reported patient was revised approximately four years post implantation due to a scarred patella.The 3 pegs broke off and remained inside the bone.A synovectomy was performed and irrigation to remove any metal debris.The patella was resurfaced; 9mm was removed off patella and implanted with a 3 peg 34mm patella.No further information is available at this time.

Event Description

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

Manufacturer Narrative

Reported event was confirmed by review of operative notes.Primary operative notes does not suggest any intra operative complications.Revision operative notes state that patella had all the three pegs had broken off.Synovectomy was performed and debris were irrigated.Dhr was reviewed and no discrepancies were found.Corrective action was initiated to address the issue of risk of fracture.Investigation results concluded that the reported event was due to 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.

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.

• 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: 9511299
• MDR Text Key: 172445354
• Report Number: 0001825034-2019-05695
• Device Sequence Number: 1
• Product Code: HRY
• UDI-Device Identifier: 0088030454429
• UDI-Public: (01)0088030454429
• Combination Product (y/n): N
• PMA/PMN Number: K171054
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,consum
• Type of Report: Initial,Followup,Followup
• Report Date: 10/14/2021

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
• Device Operator: Health Professional
• Device Expiration Date: 05/26/2020
• Device Model Number: N/A
• Device Catalogue Number: 141357
• Device Lot Number: 952030
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/20/2021
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 12/04/2019
• Initial Date FDA Received: 12/23/2019
• Supplement Dates Manufacturer Received: 02/19/2020; 10/07/2021
• Supplement Dates FDA Received: 02/21/2020; 10/14/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: Z-2068-2017
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 44 YR