MAUDE Adverse Event Report: BIOMET UK LTD. OXF ANAT BRG RT X-SM 3MM PMA; OXFORD HXLPE BEARINGS

Model Number 159590

Device Problem Device Dislodged or Dislocated (2923)

Patient Problem Joint Dislocation (2374)

Event Date 10/15/2022

Event Type  Injury  

Event Description

It was reported that the patient underwent an initial right unicondylar knee replacement.Approximately six months later revision surgery was performed due to dislocation of the bearing.Attempts have been made and no further information has been provided.

Manufacturer Narrative

(b)(4).Medical devices: oxford uni twin-peg femoral xs; item# 166940; lot# 6971292; oxf uni tib tray sza rm; item# 154719; lot# 7006094.Report source - foreign: china.The device will not be returned for analysis; however, an investigation of the reported event is in progress.Once the investigation is completed, a supplemental medwatch 3500a will be submitted.Discarded.

Manufacturer Narrative

(b)(4).This follow-up report is being submitted to relay additional and/or corrected information.No product was returned or pictures provided; visual and dimensional evaluations could not be performed.Review of the device history record identified no deviations or anomalies during manufacturing related to the reported event.Device is used for treatment.Radiographs were provided and reviewed by a health care professional.Review of the available records identified the following: implant fit and alignment are maintained on all images.Bone quality is osteopenic, dislocation of the medial unicompartmental arthroplasty bearing (liner) is confirmed followed by revision surgery with normal appearance of the arthroplasty components.No loosening, wear, or abnormal radiolucency is noted and apart from the bearing dislocation, the implants appear normally positioned.A definitive root cause cannot be determined however adherence to rehabilitation protocol could be a contributing factor.If any further information is found which would change or alter any conclusions or information, a supplemental report will be filed accordingly.Zimmer biomet will continue to monitor for trends.

Event Description

No further event information available at the time of this report.

• Brand Name: OXF ANAT BRG RT X-SM 3MM PMA
• Type of Device: OXFORD HXLPE BEARINGS
• Manufacturer (Section D): BIOMET UK LTD.; waterton industrial estates; bridgend CF31 3XA; UK CF31 3XA
• Manufacturer (Section G): BIOMET UK LTD.; waterton industrial estates; bridgend CF31 3XA; UK CF31 3XA
• Manufacturer Contact: christina arnt ; 56 e. bell dr.; warsaw, IN 46582 ; 5745273773
• MDR Report Key: 15967365
• MDR Text Key: 305334407
• Report Number: 3002806535-2022-00500
• Device Sequence Number: 1
• Product Code: NRA
• UDI-Device Identifier: 05019279786367
• UDI-Public: (01)05019279786367(17)260407(10)7000468
• Combination Product (y/n): N
• Reporter Country Code: CH
• PMA/PMN Number: P010014
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 01/11/2023

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?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: 159590
• Device Catalogue Number: 160790
• Device Lot Number: 7000468
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 11/30/2022
• Initial Date FDA Received: 12/13/2022
• Supplement Dates Manufacturer Received: 01/11/2023
• Supplement Dates FDA Received: 01/11/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 04/07/2021
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Removal/Correction Number: N/A
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 69 YR
• Patient Sex: Female