MAUDE Adverse Event Report: ZIMMER BIOMET, INC. SERIES A PAT STD 37 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	Bacterial Infection (1735); Scar Tissue (2060)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).Event date: unknown date in (b)(6) 2019.Explant date: unknown date in (b)(6) 2019.Therapy date: unknown date in (b)(6) 2019.Concomitant medical products: vngd ps open por fmrl lt 70 catalog#: 184532 lot#: 907090, biomet finned pri stem 40mm catalog#: 141314 lot#: 142140, bmet regenx pri tib tray 79mm catalog#: 141275 lot#: 610110.Customer has indicated that the product will not be returned to zimmer biomet for investigation, as its location is unknown.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 patient underwent a left knee revision.It is noted in the surgical record that the patient acquired left knee infection and subsequently underwent several i&ds (washouts) on unknown dates, and all components removed during stage i procedure were treated with iv antibiotics for six (6) weeks.Cultures were negative post treatment and the patient was then re-implanted.No additional patient consequences were reported.
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.Updated: b4, e1, g4, g7, h2, h3, h6, and h10.Reported event was confirmed by review of medical records.Medical records were provided and reviewed by a health care professional.Review of the available records identified the following: several washouts were previously performed.Old scar tissue from prior procedures was present.No complications noted.Dhr was reviewed and no discrepancies were found.Root cause was unable to 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.

• Brand Name: SERIES A PAT STD 37 3 PEG
• Common Device Name: PROSTHESIS, KNEE
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 56 e. bell drive; warsaw IN 46582
• MDR Report Key: 9928120
• Report Number: 0001825034-2020-01476
• Device Sequence Number: 2764807
• Product Code: JWH
• UDI-Device Identifier: 00880304436633
• UDI-Public: (01)00880304436633(17)200715(10)753480
• Combination Product (Y/N): N
• Initial Reporter State: GA
• Initial Reporter Country: US
• PMA/510(K) Number: K040770
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2018
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 06/11/2020

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?: No
• Operator of Device: Health Professional
• Device Expiration Date: 07/15/2020
• Device Model Number: N/A
• Device Catalogue Number: 184768
• Device Lot Number: 753480
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 03/11/2020
• Supplement Date Received by Manufacturer: 06/08/2020
• Initial Report FDA Received Date: 04/06/2020
• Supplement Report FDA Received Date: 06/11/2020
• 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