MAUDE Adverse Event Report: BIOMET UK LTD. OXF TWIN-PEG CMNTD FEM SM PMA; OXFORD CEMENTED FEMORALS

Model Number N/A

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

Patient Problem Insufficient Information (4580)

Event Date 02/07/2022

Event Type  Injury  

Event Description

It was reported, that: a patient underwent an initial right knee arthroplasty on an unknown date.Subsequently, a revision procedure due to unknown reasons was performed on (b)(6) 2022.Oxford warranty photos of the explanted items and implanted items are in the files in sms on this case.Patient involvement: no delay.

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.

Event Description

It was reported, that: a patient underwent an initial right knee arthroplasty on an unknown date.Subsequently, a revision procedure due for an unknown reason was performed on feb 7, 2022.Patient involvement.No delay.No additional information is available.

Manufacturer Narrative

(b)(4).Complaint summary: the product has not been returned for evaluation.X-rays or medical notes have not been provided.The investigation has been limited to the information provided, a review of the device history records, and a complaint history search.A review of the device history records identified no deviations or anomalies during manufacturing that could be related to the reported event.A review of complaint history identified additional similar complaints about the reported items and no additional complaints about the reported item and lot combinations these devices are used for treatment.The implants used have been confirmed to be compatible/not enough information has been provided to determine if all implants are compatible.These part and lot combinations are not associated with any recalls at the time the search was conducted.The likely condition of the devices when they left zimmer biomet is conforming to the specification.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.These part and lot combinations are not associated with any recall as of the current date.Multiple mdr reports were filed for this event, please see associated report numbers: 3002806535-2022-00077-1.3002806535-2022-00079-1.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.

• Brand Name: OXF TWIN-PEG CMNTD FEM SM PMA
• Type of Device: OXFORD CEMENTED FEMORALS
• 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: 13577815
• MDR Text Key: 288597833
• Report Number: 3002806535-2022-00078
• Device Sequence Number: 1
• Product Code: HRY
• UDI-Device Identifier: 05019279438228
• UDI-Public: 05019279438228
• 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: Health Professional,User Facility
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 05/03/2022

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
• Device Operator: Health Professional
• Device Model Number: N/A
• Device Catalogue Number: 161468
• Device Lot Number: 302650
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 02/07/2022
• Initial Date FDA Received: 02/22/2022
• Supplement Dates Manufacturer Received: 05/03/2022
• Supplement Dates FDA Received: 05/04/2022
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 10/22/2017
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: N/A
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention