MAUDE Adverse Event Report: BIOMET UK LTD. OXF ANAT BRG LT LG SIZE 3 PMA; 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	Insufficient Information (4580)
Date of Event	04/13/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).Initial final combined report.Customer has indicated that the product will not be returned to zimmer biomet for investigation.Concomitant products: medical product: oxf uni tib tray sz f lm pma, catalog #: 154775, lot #: 828320; medical product: oxf twin-peg cmntd fem lg pma, catalog #: 161470, lot #: 612410.Multiple mdr reports were filed for this event, please see associated reports: 3002806535-2021-00196, 3002806535-2021-00197.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 1 complaint reported with the item 154775, 1 complaint reported with the item 161470, and 2 complaint reported with the item 159554 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 or Problem Description
It was reported that a patient underwent an initial left knee arthroplasty on (b)(6) 2017.Subsequently, a revision procedure due to unknown reason was performed on (b)(6) 2021.

• Brand Name: OXF ANAT BRG LT LG SIZE 3 PMA
• 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: 11824318
• Report Number: 3002806535-2021-00198
• Device Sequence Number: 17204213
• Product Code: NRA
• UDI-Device Identifier: 05019279786008
• UDI-Public: (01)05019279786008(17)211214(10)348010
• Combination Product (Y/N): N
• Initial Reporter State: NC
• Initial Reporter Country: US
• PMA/510(K) Number: P01004
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2017
• Device Explanted Year: 2021
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 05/14/2021

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: 12/14/2021
• Device Model Number: N/A
• Device Catalogue Number: 159554
• Device Lot Number: 348010
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/03/2021
• Initial Report FDA Received Date: 05/14/2021
• 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; Required Intervention
• Patient Age: 78 YR