MAUDE Adverse Event Report: ZIMMER BIOMET, INC. REGENEREX SERIES-A PATELLA; KNEE PROSTHESIS

Model Number N/A

Device Problems Fracture (1260); Insufficient Information (3190); Migration (4003)

Patient Problems Pain (1994); Scar Tissue (2060); Reaction (2414)

Event Date 02/20/2019

Event Type  Injury  

Manufacturer Narrative

(b)(4).Concomitant medical products: unknown femoral component catalog # unknown lot # unknown.Unknown tibial component catalog # unknown lot # unknown.Unknown articular surface catalog # unknown lot # unknown.Customer has indicated that the product will not be returned because it remains implanted.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 that the patient underwent a knee arthroplasty.Subsequently, the patient is being considered for revision due to pain.No revision procedure has been reported to date.Attempt for further information has been made, but no further information has been provided.

Manufacturer Narrative

This follow-up report is being filled to relay additional information, which was unknown udi #: (b)(4).Medical product: vanguard cr por fmrl-lt 67.5 catalog # 183070 lot # 170190.Biomet finned pri stem 40mm catalog # 141314 lot # 732190.Bmet regenx pri tib tray 79mm catalog # 141275 lot # 600790.E1 vngd as tib brg 10x79 catalog # ep-189100 lot # 799520.

Event Description

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

Event Description

From additional information received it was reported that the patient was revised due to implant fracture and migration, pain, bone loss, metallosis, and adhesions and scar tissue.

Manufacturer Narrative

This follow-up report is being submitted to relay additional information.Reported event was confirmed by review of operative notes 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 complaint is being addressed 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.

• Brand Name: REGENEREX SERIES-A PATELLA
• Type of Device: KNEE PROSTHESIS
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 56 e. bell drive; warsaw IN 46582
• MDR Report Key: 8355764
• MDR Text Key: 136721957
• Report Number: 0001825034-2019-00729
• Device Sequence Number: 1
• Product Code: MBH
• Combination Product (y/n): N
• PMA/PMN Number: K083782
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer,distributor,health p
• Type of Report: Initial,Followup,Followup
• Report Date: 10/23/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/20/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 01/25/2021
• Device Model Number: N/A
• Device Catalogue Number: 141358
• Device Lot Number: 195630
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 10/04/2019
• 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 Weight: 86