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

Model Number N/A

Device Problem Material Integrity Problem (2978)

Patient Problem Insufficient Information (4580)

Event Date 07/13/2021

Event Type  Injury  

Manufacturer Narrative

(b)(4).Initial report: customer has indicated that the product will not be returned to zimmer biomet for investigation.Associated items only: medical product: oxford uni femoral md, catalog #:154601, lot #:2169331; medical product: oxf uni tib tray sz b rm pma, catalog #: 154721, lot #: 2141617.The investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.

Event Description

It was reported that patient underwent right partial knee procedure (b)(6) 2010.Subsequently, patient was revised (b)(6) 2021 due to poly wear.Patient was revised to a total knee.

Manufacturer Narrative

(b)(4).This final report is being submitted to relay additional information.Complaint summary: 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 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 complaint reported with the item 159576(initiating complaint).Without the opportunity to examine the complaint product, root cause cannot be determined due to insufficient information.If any additional information becomes available, then the complaint will be reopened and investigated thoroughly.Capa: no corrective or preventive action required at this time.If any further information is found which would change or alter any conclusions or information, a supplemental will be submitted accordingly.Zimmer biomet will continue to monitor for trends.H3 other text : unavailable by hospital policy.

Event Description

It was reported that patient underwent right partial knee procedure (b)(6) 2010.Subsequently, patient was revised (b)(6) 2021 due to poly wear.Patient was revised to a total knee.

• Brand Name: OXF ANAT BRG RT MD SIZE 4 PMA
• Type of Device: KNEE SYSTEM
• Manufacturer (Section D): BIOMET UK LTD.; waterton industrial estates; bridgend CF31 3XA; UK CF31 3XA
• MDR Report Key: 12196029
• MDR Text Key: 262425526
• Report Number: 3002806535-2021-00317
• 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: consumer,health professional
• Type of Report: Initial,Followup
• Report Date: 07/28/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 07/08/2015
• Device Model Number: N/A
• Device Catalogue Number: 159576
• Device Lot Number: 2115050
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 07/13/2021
• Initial Date FDA Received: 07/20/2021
• Supplement Dates Manufacturer Received: 07/28/2021
• Supplement Dates FDA Received: 07/28/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: N/A
• Patient Sequence Number: 1
• Treatment: SEE H10 NARRATIVE
• Patient Outcome(s): Hospitalization; Required Intervention