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

Model Number N/A

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

Patient Problem Pain (1994)

Event Date 08/24/2021

Event Type  Injury  

Manufacturer Narrative

(b)(4).Initial report: customer has indicated that the product has been discarded, therefore will not be returned to zimmer biomet for investigation.Medical product: oxf twin-peg cmntd fem lg pma, catalog #:161470, lot #: 915290 medical product: oxf anat brg rt lg size 4 pma, catalog #:159583, lot #: 169240 multiple mdr reports were filed for this event, please see associated reports: 3002806535-2021-,00372, 3002806535-2021-00373.The investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.

Event Description

It was reported that a patient underwent an initial right knee arthroplasty on (b)(6) 2016.Subsequently, a revision procedure due to pain was performed on (b)(6) 2021.Attempts have been made but no further information has been provided at this time.

Manufacturer Narrative

(b)(4).This final report is being submitted to relay additional information.The following sections were updated: b4, b5, g3, g6, h1, h2, h6, h10.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 any supporting documentation which could provide additional information.The source of pain cannot be determined through the radiographs, as only ap radiographs provided, no ml view so a full assessment of size, position and alignment cannot be done.A review of the manufacturing history records confirms no abnormalities or deviations reported, ncr9101 and ncr006868 were issued for item 161470 and ncr0024 was issued for item 154725.A review of the complaint database over the last 3 years has found 4 complaints reported with the item 159583, 5 complaints reported with the item 161470 and 6 complaints reported with the item 154725 (including the initiating complaint).Without the opportunity to examine the complaint product, root cause cannot be determined due to insufficient information.Capa: no corrective or preventive action required at this time.Multiple mdr reports were filed for this event, please see associated reports: 3002806535-2021-00372-1, 3002806535-2021-00373-1.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.

Event Description

It was reported that a patient underwent an initial right knee arthroplasty on (b)(6), 2016.Subsequently, a revision procedure due to pain was performed on (b)(6), 2021.Attempts have been made but no further information has been provided at this time.

• Brand Name: OXF UNI TIB TRAY SZ D RM PMA
• 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: 12406919
• MDR Text Key: 272963725
• Report Number: 3002806535-2021-00374
• Device Sequence Number: 1
• Product Code: NRA
• UDI-Device Identifier: 05019279388912
• UDI-Public: (01)05019279388912(17)261118(10)734830
• 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: 10/13/2021

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: 154725
• Device Lot Number: 734830
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 08/24/2021
• Initial Date FDA Received: 09/01/2021
• Supplement Dates Manufacturer Received: 10/13/2021
• Supplement Dates FDA Received: 10/13/2021
• 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
• Patient Age: 65 YR