MAUDE Adverse Event Report: BIOMET UK LTD. UNKNOWN OXFORD BEARING

Model Number N/A

Device Problems Break (1069); Fracture (1260); Material Integrity Problem (2978)

Patient Problems Failure of Implant (1924); Pain (1994)

Event Date 12/01/2021

Event Type  Injury  

Manufacturer Narrative

(b)(4).Initial report.Report source, foreign - event occurred in (b)(6).Customer has indicated that the product will not be returned to zimmer biomet for investigation.Concomitant medical products: associated products: medical product: unknown oxford tibia.Catalog no.: unknown.Lot no.: unknown.Medical product: unknown oxford femoral 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.Device not being returned to zb.

Event Description

It was reported that: the patient underwent an initial right knee arthroplasty in (b)(6) 2003.Subsequently, the patient was revised on (b)(6) 2021 due to pain and broken bearing.Patient outcome: revision.

Manufacturer Narrative

(b)(4).This final report is being submitted to relay additional information.Complaint summary: no product was returned or pictures provided; visual and dimensional evaluations could not be performed.A review of the device history records could not be conducted as dhr, item or lot number were not provided.The device is used for treatment.The reported product could not be reviewed for compatibility as no information was provided.A review of complaint history could not be conducted due to insufficient information.Medical records/radiographs were provided, and on review confirms the following: alignment is overall maintained.The tibial implant appears loose.Bone quality is osteopenic.Radiolucency was present along the tibial implant, which appears loose.The bearing is fractured and there is poly wear.Bearing fracture is confirmed.Tibial implant loosening could possibly contribute to this occurrence.A definitive root cause cannot be determined with the information provided, however the loosening of the tibial implant could be a contributing factor.No review of corrective actions, preventive actions, or field actions could be conducted with the information provided.The investigation is completed based on current available information.If any additional information becomes available, then the complaint will be reopened and further investigated.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 that: the patient underwent an initial right knee arthroplasty in (b)(6) 2003.Subsequently, the patient was revised on (b)(6) 2021 due to pain and broken bearing.Patient outcome: revision.

• Brand Name: UNKNOWN OXFORD BEARING
• Type of Device: UNKNOWN OXFORD BEARING
• 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: 13009655
• MDR Text Key: 282267328
• Report Number: 3002806535-2021-00529
• Device Sequence Number: 1
• Product Code: HRY
• Combination Product (y/n): N
• Reporter Country Code: AS
• PMA/PMN Number: N/A
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,User Facility
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 02/01/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/15/2021
• 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: UNKNOWN OXFORD BEARING
• Device Lot Number: UNKNOWN OXFORD BEARING
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 01/26/2022
• 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: SEEH10
• Patient Outcome(s): Required Intervention; Hospitalization
• Patient Age: 71 YR
• Patient Sex: Female