MAUDE Adverse Event Report: BIOMET UK LTD. OXF UNI TIB TRAY SZ D RM PMA; UNICONDYLAR KNEE PROSTHESIS

Model Number N/A

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Pain (1994)

Event Date 08/04/2020

Event Type  Injury  

Manufacturer Narrative

(b)(4).Initial report.Customer has indicated that the product will not be returned to zimmer biomet for investigation, as it has been discarded.Medical product: oxf twin-peg cmntd fem md pma, catalog #: 161469, lot #: 484130; medical product: oxf anat brg rt md size 3 pma, catalog #: 159575, lot #: 402130.Multiple mdr reports were filed for this event, please see associated reports: 3002806535-2020-00369.3002806535-2020-00370.The investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.Product has not been returned.

Event Description

It was reported that a patient underwent an initial right knee arthroplasty.Subsequently, the patient began exhibiting pain during normal range of motion which resulted in a revision procedure.

Manufacturer Narrative

(b)(4).Multiple mdr reports were filed for this event, please see associated reports: 3002806535-2020-00369-1, 3002806535-2020-00370-1.As the product has not been received, the investigation was limited to the information provided; a review of device history records and complaint history.In addition, we have not been provided with 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 no similar complaints reported with item and lot combinations.A review of the complaint database over the last 3 years has found 2 similar complaints reported with item 154725,15 similar complaints reported with item 161469 and 2 similar complaints reported with item 159575.Review of product deviation reports for 154725 states 12 pieces were set wrong and were reprocessed.Risk assessment: risk management report documents the estimated residual risk associated with the device within the reported event.The root cause of the issue could not be determined with the information currently available, therefore the specific failure cause within the risk tables could not be selected for comparison.The reported event states revision due to pain during normal range of motion.Pain is documented as a potential harm as an outcome of a number of hazards assessed by the above referenced rmf.Pain is considered a severity of 3: moderate, which as per the severity table listed within the rmr is defined as prescribed medical or surgical intervention to preclude permanent impairment of a body function or body structure.Contributed to minor, temporary, or medically reversible injury.The outcome of the reported event (surgical intervention) is considered to be within the severity of the rmr.No corrective or preventive actions are deemed necessary at this time.If any additional information becomes available, then the complaint will be reopened and investigated thoroughly.

Event Description

It was reported that a patient underwent an initial right knee arthroplasty.Subsequently, the patient began exhibiting pain during normal range of motion which resulted in a revision procedure.

• Brand Name: OXF UNI TIB TRAY SZ D RM PMA
• Type of Device: UNICONDYLAR KNEE PROSTHESIS
• Manufacturer (Section D): BIOMET UK LTD.; waterton industrial estates; bridgend CF31 3XA; UK CF31 3XA
• MDR Report Key: 10378439
• MDR Text Key: 202008233
• Report Number: 3002806535-2020-00368
• Device Sequence Number: 1
• Product Code: NRA
• UDI-Device Identifier: 05019279388912
• UDI-Public: 05019279388912
• 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: 09/15/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/07/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: N/A
• Device Catalogue Number: 154725
• Device Lot Number: 591770
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 09/07/2020
• 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