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

Model Number N/A

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

Patient Problems No Information (3190); Insufficient Information (4580)

Event Date 01/06/2021

Event Type  Injury  

Manufacturer Narrative

(b)(4).Initial report.Customer has indicated that the product will not be returned to zimmer biomet for investigation.Concomitant medical products: medical product: oxf uni tib tray sz b rm pma, catalog #: 154721, lot #: unknown.Medical product: oxf twin-peg cmntd fem sm pma, catalog #: 161468, lot #: unknown.Multiple mdr reports were filed for this event, please see associated reports: 3002806535-2021-00017, 3002806535-2021-00018.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 knee arthroplasty on (b)(6) 2019.Subsequently, a revision procedure due to unknown reason was performed on (b)(6) 2021.

Manufacturer Narrative

(b)(4).This follow-up report is being submitted to relay additional information.Multiple mdr reports were filed for this event, please see associated reports: 3002806535-2021-00017-1, 3002806535-2021-00018-1.Additional information received: reason for the revision: poly exchange.Lot numbers of the initial implant products received: medical product: oxf uni tib tray sz b rm pma, catalog #: 154721, lot #: 998010; medical product: oxf twin-peg cmntd fem sm pma, catalog #: 161468, lot #: 165060; medical product: oxf anat brg rt sm size 4 pma, catalog #: 159569, lot #: 679680.Initial and revision procedures performed at the same hospital and by same surgeon.The surgical technique for the product was utilized.The investigation is in process.Once the investigation has been completed, a supplemental mdr will be submitted.

Event Description

It was reported that a patient underwent an initial knee arthroplasty on (b)(6) 2019.Subsequently, a revision procedure due to poly exchange was performed on (b)(6) 2021.

Manufacturer Narrative

(b)(4).This final report is being submitted to relay additional information.Multiple mdr reports were filed for this event, please see associated reports: 3002806535-2021-00017-2, 3002806535-2021-00018-2.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 no similar complaints reported with these item numbers.Without the opportunity to examine the complaint product, root cause cannot be determined due to insufficient information.Risk assessment: a risk assessment cannot be carried out at this time, as a reason (harm) for the poly exchange has not been reported.Since the event reports revision surgery was undertaken, the outcome of this event in terms of the expected severity is as per the rmf and considered to be severity of 3: moderate ¿ prescribed medical or surgical intervention to preclude permanent impairment of a body function or body structure.Contributed to minor, temporary, or medically reversible injury.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 knee arthroplasty on (b)(4) 2019.Subsequently, a revision procedure due to poly exchange was performed on (b)(4) 2021.

• Brand Name: OXF ANAT BRG RT SM SIZE 4 PMA
• Type of Device: KNEE ARTHROPLASTY
• Manufacturer (Section D): BIOMET UK LTD.; waterton industrial estates; bridgend CF31 3XA; UK CF31 3XA
• MDR Report Key: 11228390
• MDR Text Key: 228695476
• Report Number: 3002806535-2021-00019
• 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: 02/19/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/26/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 01/21/2024
• Device Model Number: N/A
• Device Catalogue Number: 159569
• Device Lot Number: 679680
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 02/19/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: N/A
• Patient Sequence Number: 1
• Treatment: SEEH10
• Patient Outcome(s): Hospitalization; Required Intervention