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

Model Number	N/A
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Necrosis (1971); Pain (1994); Nonunion/Delayed-union Bone Fracture (2369)
Date of Event	12/21/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).Concomitant devices: vanguard as tibial bearing 10mm x 79mm catalog #: ep-189100 lot #: 139470, biomet tibial locking bar catalog #: 141205 lot #: 477710, biomet regenerex primary tibial tray 79mm catalog #: 141275 lot #: 600790, vanguard cruciate retaining porous femoral component left 67.5 catalog #: 183070 lot #: 170190, biomet finned primary stem 40mm catalog #: 141314 lot #: 732190.The complainant has indicated that the product will not be returned to zimmer biomet for investigation, as the device remains implanted.The investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.
Event or Problem Description
It was reported that the patient underwent a left knee procedure to address pain, a patellar avascular nonunion and to repair the patient's quadriceps tendon approximately twenty-one (21) months following a left knee arthroplasty revision of the patellar component.Operative notes from the procedure noted that the patellar component remained intact and appeared to be well-cemented.The anterior lateral aspect of the knee had the appearance of a patella fracture nonunion with avascular necrosis.The patellar nonunion was treated, necrotic tissue excised and the quadricipes tendon was repaired to stabilize the femur and patella.No implants were removed.Attempts have been made, however, no additional information is available at this time.
Additional Manufacturer Narrative
(b)(4).This follow-up report is being submitted to relay additional information.No product was returned or pictures provided; visual and dimensional evaluations could not be performed.Review of the device history record(s) identified no deviations or anomalies during manufacturing.Medical records were provided and reviewed by a health care professional.A definitive root cause cannot be determined.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 or Problem Description
No further event information available at the time of this report.

• Brand Name: BIOMET SERIES A STANDARD PATELLA 34MM 3 PEG
• Common Device Name: PROSTHESIS, KNEE
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 56 e. bell drive; warsaw IN 46582
• MDR Report Key: 11693779
• Report Number: 0001825034-2021-01162
• Device Sequence Number: 16917962
• Product Code: JWH
• UDI-Device Identifier: 00880304434349
• UDI-Public: (01)00880304434349(17)240113(10)023190
• Combination Product (Y/N): N
• Initial Reporter State: MI
• Initial Reporter Country: US
• PMA/510(K) Number: K040770
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2019
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: company representative,consum
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 06/10/2021

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?: No
• Operator of Device: Health Professional
• Device Expiration Date: 01/13/2024
• Device Model Number: N/A
• Device Catalogue Number: 184766
• Device Lot Number: 023190
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 04/02/2021
• Supplement Date Received by Manufacturer: 06/09/2021
• Initial Report FDA Received Date: 04/20/2021
• Supplement Report FDA Received Date: 06/15/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• If action reported to FDA under 21 USC 360i(g), list FDA-assigned Recall Number or include a statement: N/A
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention
• Patient Weight: 86