MAUDE Adverse Event Report: BIOMET UK LTD. OXF ANAT BRG LT SM SIZE 3 PMA; KNEE ARTHROPLASTY

Model Number	N/A
Medical Device Problem Code	Mechanical Problem (1384)
Health Effect - Clinical Code	Loss of Range of Motion (2032)
Date of Event	12/30/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).Initial report.Customer has indicated that the product will not be returned to zimmer biomet for investigation, as it remains implanted.Concomitant medical products: medical product: oxf uni tib tray sza lm, catalog #: 154718, lot #: 107070.Medical product: oxf twin-peg cmntd fem sm pma, catalog #: 161468, lot #: 400140.Multiple mdr reports were filed for this event, please see associated reports: 3002806535-2021-00024, 3002806535-2021-00025.The investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.Product remains implanted.
Event or Problem Description
It was reported that an initial left unilateral tka was performed on (b)(4) 2020.Subsequently, the patient had a manipulation under anaesthesia (mua) on (b)(4) 2020 due to stiffness and limited mobility.
Additional Manufacturer Narrative
(b)(4).This follow-up report is being submitted to relay additional information.Multiple mdr reports were filed for this event, please see associated reports: 3002806535-2021-00024-1, 3002806535-2021-00025-1.Additional information received: -operative notes received.-patient information received: patient name: (b)(6).Patient age: 43 years.The investigation is in process.Once the investigation has been completed, a supplemental mdr will be submitted.
Event or Problem Description
It was reported that an initial left unilateral tka was performed on (b)(6) 2020.Subsequently, the patient had a manipulation under anaesthesia (mua) on (b)(6) 2020 due to stiffness and limited mobility.
Event or Problem Description
It was reported that an initial left unilateral tka was performed on (b)(6) 2020.Subsequently, the patient had a manipulation under anaesthesia (mua) on (b)(6) 2020 due to stiffness and limited mobility.
Additional Manufacturer Narrative
(b)(4).This final report is being submitted to relay additional information.Multiple mdr reports were filed for this event, please see associated reports: 3002806535-2021-00024-2, 3002806535-2021-00025-2.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 (b)(4) complaints reported with the item 154718,(b)(4) complaints reported with the item 161468 and (b)(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.If any additional information becomes available, then the complaint will be reopened and investigated thoroughly.

• Brand Name: OXF ANAT BRG LT SM SIZE 3 PMA
• Common Device Name: KNEE ARTHROPLASTY
• Manufacturer (Section D): BIOMET UK LTD.; waterton industrial estates; bridgend CF31 3XA; UK CF31 3XA
• MDR Report Key: 11228852
• Report Number: 3002806535-2021-00026
• Device Sequence Number: 3583450
• Product Code: NRA
• UDI-Device Identifier: 05019279785865
• UDI-Public: 05019279785865
• 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): 05/11/2021

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 Expiration Date: 09/04/2025
• Device Model Number: N/A
• Device Catalogue Number: 159540
• Device Lot Number: 562700
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 01/13/2021
• Supplement Date Received by Manufacturer: 02/05/2021; 05/11/2021
• Initial Report FDA Received Date: 01/26/2021
• Supplement Report FDA Received Date: 02/08/2021; 05/11/2021
• 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
• Outcome Attributed to Adverse Event: Hospitalization; Other
• Patient Age: 43 YR
• Patient Weight: 93