MAUDE Adverse Event Report: BIOMET UK LTD. OXF UNI TIB TRAY SZA RM; OXFORD PARTIAL KNEE SYSTEM

Model Number N/A

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

Patient Problem Insufficient Information (4580)

Event Date 08/30/2021

Event Type  Injury  

Manufacturer Narrative

(b)(4).This is a combined initial / final report.Customer has indicated that the product will not be returned to zimmer biomet for investigation, as it has been discarded.Medical product: oxf anat brg rt sm size 3 pma, catalog #: 159568, lot #: 2493985.Medical product: oxf twin-peg cmntd fem sm pma, catalog #: 161468, lot #: 902210.Multiple mdr reports were filed for this event, please see associated reports: 3002806535-2021-00383, 3002806535-2021-00384.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 2 complaints reported with the item 159568, 13 complaints reported with the item 161468 and 2 complaints reported with the item 154719 (including 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.

Event Description

It was reported that a patient underwent an initial right knee arthroplasty on (b)(6) 2015.Subsequently, a revision procedure due to unknown reason was performed (b)(6) 2021.Attempts have been made but no further information has been provided.

Event Description

It was reported that a patient underwent an initial right knee arthroplasty on (b)(6) 2015.Subsequently, a revision procedure due to unknown reason was performed aug 30, 2021.Attempts have been made but no further information has been provided.

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 2 complaints reported with the item 159568 and 154719 and 13 complaints reported with the item 161468 (including the 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.Multiple mdr reports were filed for this event, please see associated reports: 3002806535-2021-00383-1; 3002806535-2021-00384-1.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 : the product has been discarded.

• Brand Name: OXF UNI TIB TRAY SZA RM
• Type of Device: OXFORD PARTIAL KNEE SYSTEM
• Manufacturer (Section D): BIOMET UK LTD.; waterton industrial estates; bridgend CF31 3XA; UK CF31 3XA
• MDR Report Key: 12446050
• MDR Text Key: 270521003
• Report Number: 3002806535-2021-00385
• Device Sequence Number: 1
• Product Code: NRA
• UDI-Device Identifier: 05019279388851
• UDI-Public: 05019279388851
• 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: 09/17/2021

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 Model Number: N/A
• Device Catalogue Number: 154719
• Device Lot Number: 720470
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 08/30/2021
• Initial Date FDA Received: 09/09/2021
• Supplement Dates Manufacturer Received: 08/30/2021
• Supplement Dates FDA Received: 09/17/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: N/A
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Other