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

Model Number N/A

Device Problems Fracture (1260); Metal Shedding Debris (1804)

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

Event Date 06/19/2017

Event Type  Injury  

Manufacturer Narrative

(b)(4).Customer has indicated that the product will not be returned to zimmer biomet for investigation, as product location is unknown.The investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.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.Product location unknown.

Event Description

It was reported that the patient was revised to address mechanical breakage of the metal backed patellar implant.Attempts have been made and no further information has been provided.

Manufacturer Narrative

The follow-up report is being submitted to relay additional information.Concomitant medical products ¿ medical product: vanguard posterior stabilized femoral component, catalog #: 184502, lot #: 182220.Biomet regenerex tibial tray, catalog #: 141272, lot #: 865280.Biomet finned stem, catalog #: 141314, lot #: 743330.Vanguard posterior stabilized bearing, catalog #: 183620, lot #: 095740.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

Operative reports received indicates that during the revision procedure the surgeon removed metallosis within the soft tissues.

Event Description

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

Manufacturer Narrative

(b)(4).This report is being submitted to relay additional information.Reported event has been confirmed by review of photos and operative notes received.Device history record (dhr) was reviewed with the following deviations: 1 piece of scrap at op 260 and one scrap at op 265 for carbon testing; 15 pieces reworked due to incorrect water being used during clearning; one unit reworked due to flash exceeding.060"; five pieces reworked due to crushed retainers; three pieces scrapped due to excess poly on the metal.The reproted event has been previously identified and was investigated as part of ca-03298.Per ca-03298, the most probable root cause of the reported event was 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 report is being submitted to relay additional information.Complaint sample was evaluated and the reported event was confirmed.Visual inspection of the returned product shows the metal pegs have sheared off and that the articulating surface has nicks and gouges from repeated use.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.

• Brand Name: REGENEREX SERIES-A PATELLA
• Type of Device: PROSTHESIS, KNEE
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 56 e. bell drive; warsaw IN 46582
• MDR Report Key: 7345524
• MDR Text Key: 102626825
• Report Number: 0001825034-2018-01993
• Device Sequence Number: 1
• Product Code: JWH
• Combination Product (y/n): N
• PMA/PMN Number: PK171054
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: other
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 01/10/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/16/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Physician
• Device Expiration Date: 09/20/2021
• Device Model Number: N/A
• Device Catalogue Number: 141355
• Device Lot Number: 705930
• Other Device ID Number: 0 0880304 55440 5
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/12/2019
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 01/09/2020
• 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: 70 YR