MAUDE Adverse Event Report: BIOMET UK LTD. UNK OXFORD BEARING; KNEE ARTHROPLASTY

Model Number N/A

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

Patient Problem Joint Dislocation (2374)

Event Date 10/21/2021

Event Type  Injury  

Manufacturer Narrative

(b)(4).Initial report.Concomitant medical products: customer has indicated that the product will not be returned to zimmer biomet for investigation, due to hospital policy.Associated products: medical product: unk oxford femoral component, catalog no.: unknown, lot no.: unknown.Medical product: unk oxford tibial component, catalog no.: unknown, lot no.: unknown.The investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.Hospital policy.

Event Description

It was reported that a patient underwent an initial right knee arthroplasty on (b)(6) 2020.Subsequently, a revision procedure due to dislocation was performed on (b)(6) 2021.Poly change.

Manufacturer Narrative

(b)(4).This final report is being submitted to relay supplemental information.Complaint summary: the 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.This device is 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 device(s) when it/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 is required at this time as the root cause of the reported event has not been determined.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 Description

It was reported, that: a patient underwent an initial right knee arthroplasty on (b)(6) 2020.Subsequently, a revision procedure due to dislocation was performed on (b)(6) 2021.Oxford warranty.Poly change due to dislocation.No further patient outcome.

• Brand Name: UNK OXFORD BEARING
• Type of Device: KNEE ARTHROPLASTY
• 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: 12758552
• MDR Text Key: 280448090
• Report Number: 3002806535-2021-00484
• Device Sequence Number: 1
• Product Code: HRY
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: N/A
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 03/03/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/07/2021
• 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 BEARING
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 03/03/2022
• 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
• Patient Outcome(s): Required Intervention; Hospitalization
• Patient Age: 54 YR
• Patient Sex: Female