MAUDE Adverse Event Report: BIOMET UK LTD. OXF ANAT BRG RT LG SIZE 6 PMA; KNEE PROSTHESIS

Model Number	N/A
Medical Device Problem Code	Noise, Audible (3273)
Health Effect - Clinical Codes	Inflammation (1932); Pain (1994)
Date of Event	04/26/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).Concomitant medical products: medical product: oxf twin-peg cmntd fem lg pma catalog #: 161470 lot #: 107140, medical product: oxf uni tib tray sz drm pma catalog #: 154725 lot #: 134580.Multiple mdr reports were filed for this event, please see associated reports: 3002806535-2019-00575, 3002806535-2019-00576.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 by the hospital that a patient underwent right knee arthroplasty.Subsequently, the patient underwent arthrotomy and debridement due to experiencing pain, popping/clicking and catching of right knee.Surgeon further reported entrapped and inflamed synovium tissue, as well as a small amount of ho bone was excised.Follow-up appointment post procedure reported symptoms were no longer present.
Additional Manufacturer Narrative
(b)(4).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.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.
Event or Problem Description
It was reported by the hospital that a patient underwent right knee athroplasty.Subsequently, the patient underwent arthrotomy and debridement due to experiencing pain, popping/clicking and catching of right knee.Surgeon further reported entrapped and inflamed synovium tissue, as well as a small amount of ho bone was excised.Follow-up appointment post procedure reported symptoms were no longer present.

• Brand Name: OXF ANAT BRG RT LG SIZE 6 PMA
• Common Device Name: KNEE PROSTHESIS
• Manufacturer (Section D): BIOMET UK LTD.; waterton industrial estates; bridgend CF31 3XA; UK CF31 3XA
• MDR Report Key: 8762254
• Report Number: 3002806535-2019-00577
• Device Sequence Number: 19407326
• Product Code: NRA
• UDI-Device Identifier: 05019279786312
• UDI-Public: 05019279786312
• Combination Product (Y/N): N
• Initial Reporter State: NJ
• Initial Reporter Country: US
• PMA/510(K) Number: P010014
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2019
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 09/18/2019

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 Expiration Date: 12/08/2020
• Device Model Number: N/A
• Device Catalogue Number: 159585
• Device Lot Number: 218940
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 06/17/2019
• Supplement Date Received by Manufacturer: 09/18/2019
• Initial Report FDA Received Date: 07/04/2019
• Supplement Report FDA Received Date: 09/18/2019
• 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
• Concomitant Medical Products and Therapy/Usage Dates: SEE H10.
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention
• Patient Weight: 91