MAUDE Adverse Event Report: BIOMET UK LTD. OXF PKS ANAT MEN BRG UHMWPE RT MED SZ 3; KNEE PROSTHESIS

Model Number N/A

Device Problem Fitting Problem (2183)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 10/18/2019

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Report source, foreign - event occurred in (b)(6).Customer has indicated that the product is in the process of being returned to zimmer biomet for investigation.Once the investigation is complete, a supplemental mdr will be submitted.The investigation is in process.Once the investigation is complete, a follow-up mdr will be submitted.

Event Description

It was reported that the surgeon was unable to insert meniscal bearing during surgery.

Manufacturer Narrative

(b)(4).This final report is being submitted to relay additional information.The following sections were updated: b1, b4, b5, d10, e2, e3, g4, g7, h1, h2, h3, h6, h10.G3: report source, foreign - event occurred in canada.Product was returned to biomet uk for evaluation and the summary of evaluation is as follows: the event reports that the meniscal bearing did not fit into the patient knee, although the same size trial had no issues.This event occurred during surgery.A non-clinically significant (<30mins) delay to surgery was reported.The complaint has not been confirmed following review of the returned device provided, which was measured and found to be within 0.2mm of the specified dimensions.A review of the device history records did not identify any discrepancies that would have contributed to the reported event.A complaint history review identified no similar complaints for the same item number.A complaint history review identified no similar complaints for the same lot number.The severity of the reported event is in line with this risk file.This device is used for treatment.The reported event is not related to a combination of products; therefore, a compatibility review is not applicable.The likely condition of the device when it left zimmer biomet is conforming to specification.No corrective action has been initiated as the reported event has not been confirmed.Risk assessment: severity assessment: this event occurred during surgery.There was a non-clinically significant delay (<30mins) to surgery reported/a.The severity score is in line with the risk file (associated harm of exposure to anaesthesia, minor).Occurrence assessment: an occurrence assessment is not required as the reported event has not been confirmed.Risk score: risk score not required at the reported event has not been confirmed.No corrective or preventive actions are deemed necessary at this time.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 the surgeon was unable to insert meniscal bearing during surgery.A new meniscal bearing was used.

• Brand Name: OXF PKS ANAT MEN BRG UHMWPE RT MED SZ 3
• Type of Device: KNEE PROSTHESIS
• Manufacturer (Section D): BIOMET UK LTD.; waterton industrial estates; bridgend CF31 3XA; UK CF31 3XA
• MDR Report Key: 9304216
• MDR Text Key: 166962740
• Report Number: 3002806535-2019-00862
• Device Sequence Number: 1
• Product Code: NRA
• UDI-Device Identifier: 05019279786213
• UDI-Public: 05019279786213
• Combination Product (y/n): N
• PMA/PMN Number: P010014
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional
• Type of Report: Initial,Followup
• Report Date: 06/16/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/11/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 02/05/2024
• Device Model Number: N/A
• Device Catalogue Number: 159575
• Device Lot Number: 6483389
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/02/2020
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 06/12/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: N/A
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization