MAUDE Adverse Event Report: ZIMMER MANUFACTURING B.V. ALL POLY PETELLA STANDARD CEMENTED SIZE 32 MM DIAMETER; PROSTHESIS, KNEE

Model Number	N/A
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Erosion (1750); Hemothorax (1896); Unspecified Infection (1930); Pain (1994); Ambulation or Postural Difficulties (2544); Swelling/ Edema (4577)
Date of Event	02/25/2021
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that a patient underwent an initial left total knee replacement performed on an unknown date with unknown product.Subsequently, the patient was revised due loosening at this time zimmer biomet product was implanted.Approximatley one year, three months post implantation the patient had an mri that showed a collection of fluid over the medial aspect of the left the gastrocnemius muscle secondary to a hematoma.Edema was also noted.The patient continued to report pain and swelling.Diagnostic imaging completed one year six months after the mri scan showed ¿evidence of loosening about the cement mantle of the tibial component¿.The patient has reported she now has a lifelong infection that has eaten some of the bone in her left leg and is required strong antibiotics for the rest of her life.Patient also reports antibiotics have impacted her ra causing persistent pain and discomfort as well as instability and now must use a brace and a cane to help support her gait.No further details or outcomes have been provided.
Additional Manufacturer Narrative
(b)(4).Customer 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.Additional associated products & mdrs: 00598003702 stemmed tibial component precoat size 4 lot# j6618905, mdr: 0001822565-2023-02986.00598801013 13mm dia 100mm l straight stem ext combined length 145mm lot# 64474731, mdr: 0002648920-2023-00257.00599401691 left size f cemented option femoral component lot# 64499165 mdr: 0001822565-2023-02987 00598801215 15mm dia 30mm l straight stem ext combined length 75mm lot# 64560563, mdr: 0002648920-2023-00258.00599003610 distal femoral augment block lot# 64156124, mdr: 0001822565-2023-02988.00596203210 articular surface lps/lps-flex 51/52-femorals size ef 10mm lot# 64348533, mdr: 0001822565-2023-02989.
Event or Problem Description
No further event information available at the time of this report.
Additional Manufacturer Narrative
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 records identified no deviations or anomalies during manufacturing related to the reported event.The reported products were reviewed for compatibility with no issues noted.Medical records were provided and reviewed by a health care professional.Review of the available records identified the following: visit 1 diagnostic imaging: x-ray lucency near tibial plate, pain and swelling are cause of imaging; visit 2 bone scan: abnormal three-phase positive scan involving the left knee concerning for hardware loosening; visit 3 clinic visit: complains of knee pain; complaint is confirmed with provided medical records.The root cause for the reported infection is determined to be unrelated to implanted zimmer biomet devices.No corrective actions, preventive actions, or field actions resulted after investigation of this event.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: ALL POLY PETELLA STANDARD CEMENTED SIZE 32 MM DIAMETER
• Common Device Name: PROSTHESIS, KNEE
• Manufacturer (Section D): ZIMMER MANUFACTURING B.V.; turpeaux industrial park; route #1 km 123.4 bldg #1; mercedita PR 00715
• Manufacturer (Section G): ZIMMER MANUFACTURING B.V.; turpeaux industrial park; route #1 km 123.4 bldg #1; mercedita PR 00715
• Manufacturer Contact: jennifer rapsavage ; 56 e. bell dr.; warsaw, IN 46582 ; 5745260384
• MDR Report Key: 18021875
• Report Number: 0002648920-2023-00259
• Device Sequence Number: 12686865
• Product Code: JWH
• UDI-Device Identifier: 00889024635388
• UDI-Public: (01)00889024635388(17)270930(10)64530938
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: K933785
• 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: Other,Consumer,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 03/05/2024

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 Model Number: N/A
• Device Catalogue Number: 00597206532
• Device Lot Number: 64530938
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/06/2023
• Supplement Date Received by Manufacturer: 03/04/2024
• Initial Report FDA Received Date: 10/27/2023
• Supplement Report FDA Received Date: 03/05/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/25/2019
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• 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
• Concomitant Medical Products and Therapy/Usage Dates: SEE H10 NARRATIVE
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Female
• Patient Weight: 76 KG