MAUDE Adverse Event Report: BIOMET UK LTD. OXF TWIN-PEG CMNTD FEM SM PMA; OXFORD PARTIAL KNEE SYSTEM

Model Number N/A

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

Patient Problem Hemorrhage/Bleeding (1888)

Event Date 10/06/2020

Event Type  Injury  

Manufacturer Narrative

(b)(4).Initial report customer has confirmed that the products remain implanted.Medical product: oxf uni tib tray sza lm, catalog #: 154718, lot #: 942230.Medical product: oxf anat brg lt sm size 3 pma, catalog #: 159540, lot #: 335230.Multiple mdr reports were filed for this event, please see associated reports: 3002806535-2021-00199, 3002806535-2021-00202.The investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.

Event Description

Mymobility clinical study: prospective multicenter longitudinal cohort study including an interventional (soc) rct sub-study reported that a patient underwent an initial left knee arthroplasty on (b)(6) 2020.Subsequently, on (b)(6) 2020 the patient attended the physician's office due to bleeding from the incision area.Diagnosis was effusion of the left knee joint, which was treated with aspiration of the knee joint 2 days later.Attempts have been made but no further information has been provided at this time.

Manufacturer Narrative

(b)(4).This follow-up report is being submitted to relay additional information.Additional information received: patient first name :(b)(6), patient last name : (b)(6), patient id : (b)(6) age : 68 patient weight : 141 lbs (63.96 kg), patient height : 5 ft 3 in (160.02 cm), bmi : 25, medication to manage the pain : tramadol.The investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.

Event Description

Mymobility clinical study: prospective multicenter longitudinal cohort study including an interventional (soc) rct sub-study reported that a patient underwent an initial left knee arthroplasty on (b)(6) 2020.Subsequently, on (b)(6) 2020 the patient attended the physician's office due to bleeding from the incision area.Diagnosis was effusion of the left knee joint, which was treated with aspiration of the knee joint 2 days later.

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, h3, 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 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 3 complaints reported with the item 154718, 8 complaints reported with the item 161468 and 4 complaints reported with the item 159540 (including initiating complaint).Without the opportunity to examine the complaint product, root cause cannot be determined due to insufficient information.Multiple mdr reports were filed for this event, please see associated reports: 3002806535-2021-00199-2 3002806535-2021-00202-2 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.Device remains implanted.

Event Description

Mymobility clinical study: prospective multicenter longitudinal cohort study including an interventional (soc) rct sub-study reported that a patient underwent an initial left knee arthroplasty on (b)(6) 2020.Subsequently, on (b)(6), 2020 the patient attended the physician's office due to bleeding from the incision area.Diagnosis was effusion of the left knee joint, which was treated with aspiration of the knee joint 2 days later.

• Brand Name: OXF TWIN-PEG CMNTD FEM SM 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: 11840078
• MDR Text Key: 251110397
• Report Number: 3002806535-2021-00201
• Device Sequence Number: 1
• Product Code: NRA
• UDI-Device Identifier: 05019279438228
• UDI-Public: (01)05019279438228(17)300313(10)175520
• Combination Product (y/n): N
• PMA/PMN Number: P01004
• 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: 08/25/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/18/2021
• 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: 161468
• Device Lot Number: 175520
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 08/24/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: N/A
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 68 YR
• Patient Weight: 64