MAUDE Adverse Event Report: BIOMET UK LTD. OXF ANAT BRG RT LG SIZE 4 PMA; KNEE PROSTHESIS

Model Number N/A

Device Problem Noise, Audible (3273)

Patient Problems Pain (1994); Swelling (2091)

Event Date 08/26/2019

Event Type  Injury  

Manufacturer Narrative

(b)(4).Concomitant medical products: medical product: oxford cementless tibia d rm catalog #: us166577 lot #: 3050481, medical product: oxf twin peg cmntls fmrl lg catalog #: 161475 lot #: 2407054.Multiple mdr reports were filed for this event, please see associated reports: 3002806535-2019-00792, 3002806535-2019-00793.The investigation is in process.Once the investigation is complete, a follow-up mdr will be submitted.

Event Description

It was reported that a patient underwent initial right knee arthroplasty.Subsequently, the patient experienced pain and swelling after hearing a snap/pop while in the gym.Treatment included the knee being aspirated and aleve prn prescribed.A revision date was planned.

Manufacturer Narrative

(b)(4).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 Description

It was reported that a patient underwent initial right knee arthroplasty.Subsequently, the patient experienced pain and swelling after hearing a snap/pop while in the gym.Treatment included the knee being aspirated and aleve prn prescribed.A revision date was planned.

Manufacturer Narrative

(b)(4).This follow-up report is being submitted to relay additional information.The investigation is in process.Once the investigation is complete, a follow-up mdr will be submitted.

Event Description

It was reported that a patient underwent initial right knee arthroplasty.Subsequently, the patient experienced pain and swelling after hearing a snap/pop while in the gym.Treatment included the knee being aspirated and aleve prn prescribed.A revision date was planned.

• Brand Name: OXF ANAT BRG RT LG SIZE 4 PMA
• Type of Device: KNEE PROSTHESIS
• Manufacturer (Section D): BIOMET UK LTD.; waterton industrial estates; bridgend CF31 3XA; UK CF31 3XA
• MDR Report Key: 9161235
• MDR Text Key: 161803990
• Report Number: 3002806535-2019-00794
• Device Sequence Number: 1
• Product Code: NRA
• Combination Product (y/n): N
• PMA/PMN Number: P010014
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial,Followup,Followup
• Report Date: 11/21/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/07/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 09/30/2019
• Device Model Number: N/A
• Device Catalogue Number: 159583
• Device Lot Number: 377130
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 11/12/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: N/A
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Weight: 102