MAUDE Adverse Event Report: BIOMET UK LTD. UNK OXFORD MEDIUM BEARING 4MM

Model Number N/A

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Failure of Implant (1924)

Event Date 02/08/2022

Event Type  Injury  

Manufacturer Narrative

(b)(4).Initial report.Report source, foreign - event occurred in (b)(6).The client has indicated that the product will not be returned to zimmer biomet for an investigation as it has been discarded.The investigation is currently underway.Once the investigation has concluded, a follow-up mdr will be submitted.

Event Description

It was reported, that: a patient underwent an initial knee arthroplasty on an unknown date.Subsequently, a revision procedure due to implant fracture was performed on (b)(6) 2022.Primary approx 19 years ago but the date is unknown.Patient outcome: revision.

Event Description

It was reported, that: a patient underwent an initial knee arthroplasty on an unknown date.Subsequently, a revision procedure due to implant fracture was performed on (b)(6) 2022.Primary approx 19 years ago but the date is unknown.Patient outcome: revision.

Manufacturer Narrative

(b)(4).This final report is being submitted to relay additional information.Complaint summary: adequate photographs have not been provided and product has not been returned for evaluation.Therefore, the investigation has been limited to the information provided.Review of the device history records could not be conducted as the lot number is unknown.Review of complaint history could not be performed as the lot./ item no.Are unknown.A review of the pre revision x-ray provided is inconclusive as post-primary radiographs are needed in order to assess the initial component size, position and alignment.This device is used for treatment.The reported event is not related to a combination of products; therefore, a compatibility review is not applicable.It cannot be confirmed that the implant is not within the scope or subject of any field actions or recalls which could be attributed to reported event as the lot./ item no.Are unknown.The likely condition of the device when it left zimmer biomet is conforming to specification.The reported event has not been confirmed as relevant photographs have not been provided and product has not been returned for evaluation.The root cause of the reported event cannot be determined 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.

• Brand Name: UNK OXFORD MEDIUM BEARING 4MM
• Type of Device: UNK OXFORD MEDIUM BEARING 4MM
• 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: 13577207
• MDR Text Key: 285937905
• Report Number: 3002806535-2022-00075
• 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: 03/18/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/22/2022
• 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 MEDIUM BEARING 4MM
• 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: 03/17/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Removal/Correction Number: N/A
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Sex: Male