MAUDE Adverse Event Report: ZIMMER BIOMET, INC. ARTICULAR SURFACE 10 MM HEIGHT; PROSTHESIS, KNEE

Model Number	N/A
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Muscular Rigidity (1968); Loss of Range of Motion (2032); Ambulation or Postural Difficulties (2544); Limited Mobility Of The Implanted Joint (2671)
Date of Event	08/18/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).Concomitant medical devices: item 00575201501 lot 64169588; item 00597206532 lot 64143810; item 00598603701 lot 63980326.Foreign (b)(6).Customer has indicated that the product will not be returned to zimmer biomet for investigation as the product remains implanted.The investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.Multiple mdr reports were filed for this event, please see associated reports: 0001822565-2021-00294, 0002648920-2021-00018.
Event or Problem Description
It was reported that approximately 1 year post a left tka, the patient underwent manipulation under anesthesia due to stiffness and difficulty ambulating.Attempts have been made and no further information has been provided.
Event or Problem Description
No further event information available at the time of this report.
Additional Manufacturer Narrative
(b)(4).This complaint was not confirmed as official medical records were not provided.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.Joint assist records were provided and reviewed by a health care professional.Review found at 1 year visit patient had difficulty ambulating and stiffness.Patient had mua and was resolved.Further medical records were not provided.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.

• Brand Name: ARTICULAR SURFACE 10 MM HEIGHT
• Common Device Name: PROSTHESIS, KNEE
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 56 e. bell drive; warsaw IN 46582
• MDR Report Key: 11266672
• Report Number: 0001822565-2021-00295
• Device Sequence Number: 14233242
• Product Code: JWH
• UDI-Device Identifier: 00889024263567
• UDI-Public: (01)00889024263567(17)261031(10)64198343
• Combination Product (Y/N): N
• Initial Reporter Country: DA
• 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: company representative,distri
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 03/22/2021

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?: Yes
• Operator of Device: Health Professional
• Device Model Number: N/A
• Device Catalogue Number: 90597003010
• Device Lot Number: 64198343
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 01/25/2021
• Supplement Date Received by Manufacturer: 03/16/2021
• Initial Report FDA Received Date: 02/02/2021
• Supplement Report FDA Received Date: 03/22/2021
• 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 Age: 57 YR
• Patient Weight: 102