MAUDE Adverse Event Report: BIOMET UK LTD. OXF ANAT BRG RT SM SIZE 4 PMA; OXFORD PARTIAL KNEE SYSTEM

Model Number N/A

Device Problem Device Dislodged or Dislocated (2923)

Patient Problem Joint Dislocation (2374)

Event Date 05/04/2021

Event Type  Injury  

Manufacturer Narrative

(b)(4).Initial report: customer has indicated that the product will not be returned to zimmer biomet for investigation.Unique identifier (udi) number: (b)(4).Associated products: medical product: oxf twin-peg cmntd fem sm pma, catalog #: 161468, lot #: 290720.Medical product: oxf uni tib tray sz b rm pma, catalog #: 154721, lot #: 147420.The investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.

Event Description

It was reported that a patient underwent an initial right knee arthroplasty on (b)(6) 2017.Subsequently, a revision procedure due to bearing dislocation was performed on (b)(6) 2021.

Manufacturer Narrative

(b)(4).This final report is being submitted to relay additional information.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 last 3 years has found 2 complaint reported with the same item number (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.Capa: no corrective or preventive action required at this time.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.H3 other text : hospital discarded as biohazard.

Event Description

It was reported that a patient underwent an initial right knee arthroplasty on an (b)(6) 2017 subsequently, a revision procedure due to bearing dislocation was performed on (b)(6) 2021.

• Brand Name: OXF ANAT BRG RT SM SIZE 4 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: 11892887
• MDR Text Key: 252911274
• Report Number: 3002806535-2021-00235
• Device Sequence Number: 1
• Product Code: NRA
• UDI-Device Identifier: 05019279786152
• UDI-Public: (01)05019279786152(17)220807(10)296850
• 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
• Report Date: 07/14/2021

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
• Device Operator: Health Professional
• Device Expiration Date: 06/07/2022
• Device Model Number: N/A
• Device Catalogue Number: 159569
• Device Lot Number: 296850
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 05/05/2021
• Initial Date FDA Received: 05/27/2021
• Supplement Dates Manufacturer Received: 07/14/2021
• Supplement Dates FDA Received: 07/14/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: N/A
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Weight: 90