MAUDE Adverse Event Report: BIOMET UK LTD. OXF ANAT BRG LT MD SIZE 3 PMA; KNEE PROSTHESIS

Model Number N/A

Device Problem Insufficient Information (3190)

Patient Problems Pain (1994); Swelling (2091)

Event Date 11/26/2019

Event Type  Injury  

Manufacturer Narrative

(b)(4).Report source, foreign country: event occurred in (b)(6).Concomitant medical products: medical product: oxford uni twin-peg femoral md catalog #: 166942, lot #: j3693126.Medical product: oxf uni tib tray sz e lm pma catalog #: 154726, lot #: 3804822.Multiple mdr reports were filed for this event, please see associated reports: 3002806535-2019-00921, 3002806535-2019-00920.The investigation is in process.Once the investigation is complete, a follow-up mdr will be submitted.

Event Description

It was reported that the patient contained to be experiencing pain, swelling and instability in left knee.

Event Description

It was reported that the patient underwent an initial left knee replacement procedure.On (b)(6), 2019, it was reported that the patient contained to be experiencing pain, swelling and instability in left knee.

Manufacturer Narrative

(b)(4).Report source, foreign - event occurred in (b)(6).Concomitant medical products: medical product: oxford uni twin-peg femoral md, catalog #: 166942, lot #: j3693126, medical product: oxf uni tib tray sz e lm pma, catalog #: 154726, lot #: 3804822.Multiple mdr reports were filed for this event, please see associated reports: 3002806535-2019-00920-1, 3002806535-2019-00921-1.As the product has not been received, the investigation was limited to the information provided; a review of device history records and complaint history.We have not been provided with x-rays or any supporting documentation which could provide additional information.A review of the manufacturing history records confirms no abnormalities or deviations reported.A review of the complaint database over the last 3 years has found 1 similar complaint reported with the item 166942,6 similar complaints reported with the item 154726 and 11 similar complaints reported with the item 159547.Without the opportunity to examine the complaint product, root cause cannot be determined due to insufficient information.The reported event states ¿pain¿.In the above risk file, pain is considered harm with a severity level of 3 for a number of hazards defined as moderate, which is described in the severity table as: s-3 prescribed medical or surgical intervention to preclude permanent impairment of a body function or body structure.Contributed to minor, temporary, or medically reversible injury.Swelling and instability are also considered as harms for multiple lines in the risk file (skn002.Rmr.04 rev 04) with a severity score not exceeding 3.The outcome of this complaint is therefore considered to be within the severity of the rmr.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 ANAT BRG LT MD SIZE 3 PMA
• Type of Device: KNEE PROSTHESIS
• Manufacturer (Section D): BIOMET UK LTD.; waterton industrial estates; bridgend CF31 3XA; UK CF31 3XA
• MDR Report Key: 9458008
• MDR Text Key: 180329148
• Report Number: 3002806535-2019-00922
• 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,foreig
• Type of Report: Initial,Followup
• Report Date: 03/25/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/12/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 04/12/2021
• Device Model Number: N/A
• Device Catalogue Number: 159547
• Device Lot Number: 3777301
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 03/11/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: N/A
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Other