MAUDE Adverse Event Report: ZIMMER TMT NEXGEN COMPLETE KNEE SOLUTION TM AUGMENTATION PATELLA; TM PATELLA

Model Number	00-5876-010-19
Health Effect - Clinical Code	Pain (1994)
Date of Event	12/31/2012
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).Investigation in progress.Device evaluated by mfr: customer has indicated that the product will not be returned to zimmer biomet for investigation.The investigation is in process.
Event or Problem Description
It was reported that a patient underwent a procedure to revise the patella implant due to pain, instability, and loosening on (b)(6) 2012.Subsequently the patient underwent a second revision of the patella due to pain and instability on (b)(6) 2012.A surgical revision and patellectomy was performed.The patella bone was replaced by a fully prosthetic implant.
Event or Problem Description
Patient revised due to pain and instability.
Additional Manufacturer Narrative
No device was returned for evaluation, therefore only a device history review was performed.Device history records were reviewed for the part# 00587601019 and lot# 62063833 aug patella and no deviations or anomalies were found.Surgical notes were not provided; it is unknown whether the components were implanted with the correct fit and orientation as per the surgical technique.X-rays were not provided.This device is used for treatment.Review of complaint history identified no additional reports for lot 62063833.No medical records were provided.No corrective actions, preventive actions, or field actions resulted after investigation of this event.Due to the litigation process, little detail is available to aid in this investigation at this time.A definitive root cause cannot be determined.Should additional information be obtained to further this investigation, this report shall be updated.Method codes: analysis of production records.Device not returned.Insufficient information available.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay additional information.No devices or photos were received; therefore the condition of the components is unknown.The dhr was reviewed and no discrepancies relevant to the reported event were found.Per the package insert pi015, rev j (nexgen complete knee solution augmentation patella) and the label associated with this product, the reported combination of device is incompatible which is off label use that has likely contributed to the reported event.If any further information is found which would change or alter any conclusions or information, a supplemental report will be filed accordingly.Zimmer biomet will continue to monitor for trends.
Event or Problem Description
No further event information available at the time of this report.

• Brand Name: NEXGEN COMPLETE KNEE SOLUTION TM AUGMENTATION PATELLA
• Common Device Name: TM PATELLA
• Manufacturer (Section D): ZIMMER TMT; 10 pomeroy road; parsippany NJ 07054
• MDR Report Key: 8739135
• Report Number: 3005751028-2019-00016
• Device Sequence Number: 14094886
• Product Code: JWH
• UDI-Device Identifier: 00889024309647
• UDI-Public: (01)00889024309647(17)170430(10)62063833
• Combination Product (Y/N): N
• PMA/510(K) Number: K004013
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2012
• Device Explanted Year: 2012
• Reporter Type: Manufacturer
• Report Source: consumer,health professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 04/29/2020

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
• Operator of Device: Health Professional
• Device Expiration Date: 04/30/2017
• Device Model Number: 00-5876-010-19
• Device Catalogue Number: 00587601019
• Device Lot Number: 62063833
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 06/13/2019
• Supplement Date Received by Manufacturer: 06/13/2019; 04/29/2020
• Initial Report FDA Received Date: 06/27/2019
• Supplement Report FDA Received Date: 08/23/2019; 04/29/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention