MAUDE Adverse Event Report: BIOMET UK LTD. OXFORD CEMENTLESS TIBIA B RM; KNEE PROSTHESIS

Model Number N/A

Device Problem Material Twisted/Bent (2981)

Patient Problems Pain (1994); Swelling (2091)

Event Date 09/02/2019

Event Type  Injury  

Manufacturer Narrative

(b)(4).Concomitant medical products: medical product: oxf twin peg cmntls fmrl sm catalog #: 161473 lot #: 2409851, medical product: oxf anat brg rt sm size 4 pma catalog #: 159569 lot #: 552060.Multiple mdr reports were filed for this event, please see associated reports: 3002806535-2019-00790, 3002806535-2019-00789.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 knee surgery.Subsequently, the patient twisted the right knee which caused knee strain.This resulted in pain and swelling from thigh to ankle.Treatment included anti-inflammatory medication and the use of a knee brace.

Event Description

It has been reported that the right knee has been twisted, causing right knee straining.This resulted in pain and swelling from thigh to ankle.Treatment included anti-inflammatories and the use of a knee brace.

Manufacturer Narrative

(b)(4).D11: medical product: oxf twin peg cmntls fmrl sm, catalog#: 161473, lot#: 2409851.Medical product: oxf anat brg rt sm size 4 pma, catalog#: 159569, lot#: 552060.Multiple mdr reports were filed for this event, please see associated reports: 3002806535-2019-00789-1, 3002806535-2019- 00790-1.This follow-up report is being submitted to relay additional information.Reported event was confirmed by review of x-rays provided.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.

• Brand Name: OXFORD CEMENTLESS TIBIA B RM
• Type of Device: KNEE PROSTHESIS
• Manufacturer (Section D): BIOMET UK LTD.; waterton industrial estates; bridgend CF31 3XA; UK CF31 3XA
• MDR Report Key: 9161127
• MDR Text Key: 161774653
• Report Number: 3002806535-2019-00791
• 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
• Report Date: 01/25/2020

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 Model Number: N/A
• Device Catalogue Number: US166573
• Device Lot Number: R3050463A
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 01/03/2020
• 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: 72