MAUDE Adverse Event Report: ZIMMER BIOMET, INC. PARTIAL ARTICULAR SURFACE LEFT MEDIAL SIZE H 9 MM THICKNESS; PROSTHESIS, KNEE

Model Number	N/A
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Pain (1994); Ambulation or Postural Difficulties (2544)
Date of Event	04/17/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).Age or date of birth: (b)(6).Mfr site: (b)(4).Reported event was unable to be confirmed due to limited information received from the customer.Device remains implanted, therefore no visual inspection can be performed.Device history record (dhr) was reviewed and no discrepancies were found.Medical records were provided and reviewed by a health care professional.The medical records identified: moderate pain, difficulty ambulating for periods of time greater than 30 minutes, mild medial joint line pain, dissatisfied with end results, and patient is anxious and depressed.A definitive root cause cannot be determined.Additional associated products and mdrs: 42558000601 partial femur cemented size 6 left medial lot# 63458359 mdr: 0001825034-2021-01650; 42538000801 partial tibial cemented size h left medial lot# 63419150 mdr: 0001825034-2021-01651.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
It was reported that primary left partial knee was performed.Subsequently at the 1 year clinical visit patient reports moderate pain, decline in adls, decline in ambulating and dissatisfied.Patient remains implanted.

• Brand Name: PARTIAL ARTICULAR SURFACE LEFT MEDIAL SIZE H 9 MM THICKNESS
• Common Device Name: PROSTHESIS, KNEE
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 56 e. bell drive; warsaw IN 46582
• MDR Report Key: 11900827
• Report Number: 0001822565-2021-01465
• Device Sequence Number: 14338272
• Product Code: HSX
• UDI-Device Identifier: 00880304818545
• UDI-Public: (01)00880304818545(17)210731(10)63425060
• Combination Product (Y/N): N
• Initial Reporter Country: BE
• PMA/510(K) Number: K161592
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2017
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 05/27/2021

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: 07/31/2021
• Device Model Number: N/A
• Device Catalogue Number: 42518200809
• Device Lot Number: 63425060
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/24/2021
• Initial Report FDA Received Date: 05/28/2021
• 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
• Patient Age: 84 YR
• Patient Weight: 72