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	Device Dislodged or Dislocated (2923)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	04/02/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).This is a combined initial/ final report.As the product has not been received, the investigation was limited to the information provided; a review of device history records and complaint history.We have not been provided with x-rays or any supporting documentation which could provide additional information.A review of the device history records did not identify any discrepancies that would have contributed to the reported event.A review of the complaint database over the last 3 years has found 3 similar complaints 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 a left knee a revision procedure due to bearing dislocation.It was reported that no further information is available.
Additional Manufacturer Narrative
(b)(4).This final follow-up report is being submitted to relay additional information.Additional information received: associated product information received.Description: oxf uni tib tray sz f lm pma: item: 154775.Lot: 632510.Description: oxf twin-peg cmntd fem lg pma: item: 161470.Lot: unknown.
Event or Problem Description
It was reported that a patient underwent a left knee revision procedure due to bearing dislocation.

• 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: 11731252
• Report Number: 3002806535-2021-00140
• Device Sequence Number: 11720731
• Product Code: NRA
• UDI-Device Identifier: 05019279786008
• UDI-Public: 05019279786008
• Combination Product (Y/N): N
• Initial Reporter State: PA
• Initial Reporter Country: US
• PMA/510(K) Number: P01004
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2020
• Device Explanted Year: 2021
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 06/15/2021

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: 04/29/2024
• Device Model Number: N/A
• Device Catalogue Number: 159554
• Device Lot Number: 195170
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 04/05/2021
• Supplement Date Received by Manufacturer: 06/11/2021
• Initial Report FDA Received Date: 04/27/2021
• Supplement Report FDA Received Date: 06/15/2021
• 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