MAUDE Adverse Event Report: BIOMET UK LTD. OXF TWIN-PEG CMNTD FEM LG PMA; KNEE PROSTHESIS

Model Number	N/A
Medical Device Problem Code	Insufficient Device Problem Information (3190)
Health Effect - Clinical Codes	Edema (1820); Fever (1858); Pain (1994)
Date of Event	06/26/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).Concomitant medical products: medical product: oxf anat brg lt lg size 3 pma catalog #: 159554 lot #: 754110, medical product: oxf uni tib tray sz e lm pma catalog #: 154726 lot #: 2446499.Multiple mdr reports were filed for this event, please see associated reports: 3002806535-2019-00861, 3002806535-2019-00859.The investigation is in process.Once the investigation is complete, a follow-up mdr will be submitted.
Event or Problem Description
It was reported that a patient underwent an initial left knee replacement procedure.5 years post-op, the patient began experiencing pain, redness and edema in his left leg together with a fever (cellulitis).These symptoms occurred 2-3 days after a return flight from (b)(6).The patient was admitted to hospital for 7 days.Treatment included iv antibiotics, the patient also needed to wear compression stockings and keep leg elevated.
Event or Problem Description
It was reported that a patient underwent an initial left knee replacement procedure.5 years post-op, the patient began experiencing pain, redness and edema in his left leg together with a fever (cellulitis).These symptoms occurred 2-3 days after a return flight from italy.The patient was admitted to hospital for 7 days.Treatment included iv antibiotics, the patient also needed to wear compression stockings and keep leg elevated.
Additional Manufacturer Narrative
(b)(4).D11: medical product: oxf anat brg lt lg size 3 pma, catalog #:159554, lot #: 754110.Medical product:oxf uni tib tray sz e lm pma, catalog #: 154726, lot #: 2446499.Multiple mdr reports were filed for this event, please see associated reports: 3002806535-2019-00861-1, 3002806535-2019- 00859-1.This follow-up report is being submitted to relay additional information.The following sections were updated:b4, b5, g4, g7, h1, h2, h6, h10.Reported event was unable to be confirmed due to limited information received from the customer.Device history record (dhr) was reviewed and no discrepancies were found.The clinical report form indicated that the event is irrelevant to the device.Root cause was unable to be determined as the necessary information to adequately investigate the reported event was not provided.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: OXF TWIN-PEG CMNTD FEM LG PMA
• Common Device Name: KNEE PROSTHESIS
• Manufacturer (Section D): BIOMET UK LTD.; waterton industrial estates; bridgend CF31 3XA; UK CF31 3XA
• MDR Report Key: 9304122
• Report Number: 3002806535-2019-00860
• Device Sequence Number: 11353566
• Product Code: NRA
• UDI-Device Identifier: 05019279438259
• UDI-Public: 05019279438259
• Combination Product (Y/N): N
• Initial Reporter State: IN
• Initial Reporter Country: US
• PMA/510(K) Number: P010014
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2014
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 01/21/2020

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: 07/31/2021
• Device Model Number: N/A
• Device Catalogue Number: 161470
• Device Lot Number: 2465527
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 10/22/2019
• Supplement Date Received by Manufacturer: 12/27/2019
• Initial Report FDA Received Date: 11/11/2019
• Supplement Report FDA Received Date: 01/22/2020
• 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
• Patient Weight: 90