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

Model Number	N/A
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Hemorrhage/Blood Loss/Bleeding (1888)
Date of Event	10/06/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).Initial report.Customer has confirmed that the products remain implanted.Medical product: oxf twin-peg cmntd fem sm pma, catalog #: 161468, lot #: 175520.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: 3002806535-2021-00201, 3002806535-2021-00202.The investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.
Event or Problem Description
(b)(6) 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.
Event or Problem 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.
Additional Manufacturer Narrative
(b)(4).This follow-up report is being submitted to relay additional information.Additional information received: patient first name: (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 or Problem 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.
Additional Manufacturer Narrative
(b)(4) 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: 3002806535-2021-00201-2.3002806535-2021-00202-2.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.

• Brand Name: OXF UNI TIB TRAY SZA LM
• Common Device Name: OXFORD PARTIAL KNEE SYSTEM
• Manufacturer (Section D): BIOMET UK LTD.; waterton industrial estates; bridgend CF31 3XA; UK CF31 3XA
• MDR Report Key: 11840083
• Report Number: 3002806535-2021-00199
• Device Sequence Number: 14618324
• Product Code: NRA
• UDI-Device Identifier: 05019279388844
• UDI-Public: (01)05019279388844(17)290325(10)942230
• Combination Product (Y/N): N
• Initial Reporter State: MI
• Initial Reporter Country: US
• PMA/510(K) Number: P010014
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2020
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 08/25/2021

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
• Operator of Device: Health Professional
• Device Model Number: N/A
• Device Catalogue Number: 154718
• Device Lot Number: 942230
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 05/03/2021
• Supplement Date Received by Manufacturer: 05/27/2021; 08/24/2021
• Initial Report FDA Received Date: 05/18/2021
• Supplement Report FDA Received Date: 06/14/2021; 08/25/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• If action reported to FDA under 21 USC 360i(g), list FDA-assigned Recall Number or include a statement: N/A
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: SEE H10 NARRATIVE.
• Outcome Attributed to Adverse Event: Other
• Patient Age: 68 YR
• Patient Weight: 64