MAUDE Adverse Event Report: BIOMET UK LTD. UNKNOWN OXFORD TIBIAL COMPONENT; OXFORD PARTIAL KNEE SYSTEM

Model Number N/A

Device Problems Mechanical Problem (1384); Device Dislodged or Dislocated (2923); Unintended Movement (3026)

Patient Problems Joint Dislocation (2374); Insufficient Information (4580)

Event Date 04/21/2021

Event Type  Injury  

Manufacturer Narrative

(b)(4).Initial report: product location is currently unknown.Medical product: unknown oxford bearing, catalog #: unknown, lot #: unknown.Please see associated reports: 3002806535-2021-00411.The investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.

Event Description

It was reported by the patient¿s attorney, that the patient underwent an initial right knee arthroplasty on (b)(6) 2017.Subsequently, a revision procedure due to dislocation was performed on (b)(6) 2021.A second revision procedure due to dislocation was performed on (b)(6) 2021 when both the oxford bearing and tibial component were revised.

Manufacturer Narrative

(b)(4).This final report is being submitted to relay additional information.Complaint summary: product has not been returned for evaluation.The item and lot number have not been provided.X-rays or medical notes have not been provided.The investigation has been limited to the information provided.A historical search could not be performed as the item and lot number have not been provided.These devices are used for treatment.Not enough information has been provided to determine if all implants are compatible.A dhr review or a review of recalls could not be performed as the item and lot number have not been provided.The likely condition of the devices when they left zimmer biomet could not be determined as the item and lot number has not been provided.The root cause of the reported event can not be determined with the information provided.No corrective action required at this time as the root cause of the reported event has not been determined.No corrective or preventive action required at this time.Multiple mdr reports were filed for this event, please see associated report numbers: 3002806535-2021-00411-1.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.

Event Description

It was reported by the patient¿s attorney, that: the patient underwent an initial right knee arthroplasty on (b)(6) 2017.Subsequently, a revision procedure due to dislocation was performed on (b)(6) 2021 (b)(4).A second revision procedure due to dislocation was performed on (b)(6) 2021 when both the oxford bearing and tibial component were revised.Patient involvement.

Event Description

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

Manufacturer Narrative

This follow-up report is being submitted to relay additional and corrected information.Review of the op notes does not hold further information which might help identify the cause of the second revision.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.

• Brand Name: UNKNOWN OXFORD TIBIAL COMPONENT
• Type of Device: OXFORD PARTIAL KNEE SYSTEM
• 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: 12539491
• MDR Text Key: 273538041
• Report Number: 3002806535-2021-00408
• Device Sequence Number: 1
• Product Code: NRA
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P010014
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Consumer
• Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date: 10/13/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/28/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: N/A
• Device Catalogue Number: UNK OXFORD TIBIAL COMPONENT
• Device Lot Number: N/A
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 10/12/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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
• Treatment: SEE H10 NARRATIVE
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Sex: Male
• Patient Weight: 104 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White