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

Model Number N/A

Device Problem Fracture (1260)

Patient Problem No Information (3190)

Event Date 02/10/2020

Event Type  Injury  

Manufacturer Narrative

(b)(4).Medical product: vgd ps open por fem rt 62.5 catalog # 184506 lot # 592860; bmet regenx pri tib tray 67mm catalog # 141272 lot # 937420; biomet finned pri stem 40mm catalog # 141314 lot # 342620; e1 vngd ps tib brg 63/67x10 catalog # ep-183620 lot # 587500.Customer has indicated that the product will not be returned because product location is unknown.Reported event was confirmed by review of medical records provided.Device was not returned.Device history record (dhr) was reviewed and no discrepancies relevant to the reported event were found.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.The event is being addressed through the capa process.Medical records review indicates that two patella pegs were fractured.There was no synovitis or metallosis seen.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

It was reported that the patient underwent a knee arthroplasty.Subsequently, the patient was revised due to two fractured pegs on the patella prosthesis.The patella was removed and replaced.

Manufacturer Narrative

H6- type of investigation - device not return is n/a which was reported on initial report.Complaint sample was evaluated and the reported event was confirmed.Visual evaluation of the returned device shows wear/discoloration / foreign material and two of the posts have fractured.The additional information received doesn't change the previous investigation.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: REGENERX 3 PEG SER A PATELLA 28MM
• Type of Device: PROSTHESIS, KNEE
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 56 e. bell drive; warsaw IN 46582
• MDR Report Key: 10372592
• MDR Text Key: 201884268
• Report Number: 0001825034-2020-03017
• Device Sequence Number: 1
• Product Code: OIY
• UDI-Device Identifier: 00880304554405
• UDI-Public: (01)00880304554405
• Combination Product (y/n): N
• PMA/PMN Number: K171054
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer,distributor,health p
• Type of Report: Initial,Followup
• Report Date: 10/06/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/06/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 09/08/2020
• Device Model Number: N/A
• Device Catalogue Number: 141355
• Device Lot Number: 044830
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/10/2021
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 10/04/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: N/A
• Patient Sequence Number: 1
• Treatment: SEE H10 NARRATIVE
• Patient Outcome(s): Hospitalization; Required Intervention