MAUDE Adverse Event Report: BIOMET UK LTD. OXF ANAT BRG LT MD SIZE 6 PMA; OXFORD HXLPE BEARINGS

Model Number	N/A
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/05/2022
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported, that: the patient has oxford implanted from the 2018 surgery.Poly became dislocated anteriorly so revision was necessary to increase poly thickness and relocate.Patient involved.
Additional Manufacturer Narrative
(b)(4).Initial report.The client has indicated that the product will not be returned to zimmer biomet for an investigation.The investigation is currently underway.Once the investigation has concluded, a follow-up mdr will be submitted.
Additional Manufacturer Narrative
(b)(4).This final report is being submitted to relay supplemental information.Complaint summary: dimensional and visual inspection of the part could not be conducted as the product was not returned or photographs provided by the complainant for review to confirm the reported event.The device history records for item # 159550 lot # 409830 were reviewed for deviations and/or anomalies with no anomalies/deviations identified.The device is used for treatment.Compatibility review was not applicable for the reported event.The complaint history review for 159550 did not identify any previous complaints.Medical records/radiographs were not provided.The likely condition of the device when it left zimmer biomet is conforming to the specification.The reported event has not been confirmed as the products have not been returned for evaluation and the dhr review could not be reviewed to identify any issues as the lot number was not provided.The definitive root cause of the reported event cannot be determined with the information provided.No corrective actions, preventive actions, or field actions resulted after the investigation of this event.If any additional information is discovered or received that may adjust any conclusions or data, a supplemental report will be rendered accordingly.Zimmer biomet will continue to monitor for trends.
Event or Problem Description
It was reported, that: the patient has oxford implanted from the 2018 surgery.Poly became dislocated anteriorly so revision was necessary to increase poly thickness and relocate.Patient involved.

• Brand Name: OXF ANAT BRG LT MD SIZE 6 PMA
• Common Device Name: 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: 14110883
• Report Number: 3002806535-2022-00218
• Device Sequence Number: 4776255
• Product Code: NRA
• UDI-Device Identifier: 05019279785964
• UDI-Public: 05019279785964
• Combination Product (Y/N): N
• Initial Reporter State: VA
• Initial Reporter Country: US
• PMA/510(K) Number: N/A
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 05/17/2022

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: 11/22/2021
• Device Model Number: N/A
• Device Catalogue Number: 159550
• Device Lot Number: 409830
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/05/2022
• Supplement Date Received by Manufacturer: 05/16/2022
• Initial Report FDA Received Date: 04/14/2022
• Supplement Report FDA Received Date: 05/17/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 11/22/2016
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Unknown
• 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: Required Intervention; Hospitalization
• Patient Sex: Male