MAUDE Adverse Event Report: BIOMET UK LTD. OXF TWIN-PEG CMNTD FEM MD 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 11/18/2021

Event Type  Injury  

Manufacturer Narrative

(b)(4).Initial report.Customer has indicated that the product is in process of being returned to zimmer biomet for investigation.Multiple mdr reports were filed for this event, please see associated reports: 3002806535-2021-00512, 3002806535-2021-00513.The investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.

Event Description

It was reported that a patient underwent an initial left knee arthroplasty on (b)(6) 2020.Subsequently, a revision procedure due to unknown reason was performed on (b)(6) 2021.

Event Description

It was reported that a patient underwent an initial left knee arthroplasty on (b)(6) 2020.Subsequently, a revision procedure due to unknown reason was performed on (b)(6) 2021.

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.Review of the device history records confirmed that final release approval verified that the parts were manufactured and sterilised in accordance with the applicable specifications with no deviations or non-conformances found during manufacturing and inspection.The device is used for treatment.The reported product was reviewed for compatibility with no issues noted.A review of complaint history found no additional related issues for this item and the reported part and lot combination.It has been confirmed that the implants are not within the scope or subject of any field actions or recalls which could be attributed to reported event.Medical records/radiographs were not provided.A definitive root cause cannot be determined.The likely condition of the devices when they left zimmer biomet is conforming to specification.The reported event has not been confirmed as the products have not been returned for evaluation and the dhr review did not identify any issues.The root cause of the reported event cannot be determined with the information provided.No corrective actions, preventive actions, or field actions resulted after the investigation of this event.Multiple mdr reports were filed for this event, please see associated reports: 3002806535-2021-00512-1, 3002806535-2021-00513-1.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.H3 other text : product discarded.

• Brand Name: OXF TWIN-PEG CMNTD FEM MD 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: 12881095
• MDR Text Key: 281313915
• Report Number: 3002806535-2021-00514
• Device Sequence Number: 1
• Product Code: NRA
• UDI-Device Identifier: 05019279438242
• UDI-Public: 05019279438242
• 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: Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 01/17/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/29/2021
• 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: 161469
• Device Lot Number: 642250
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 01/17/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 07/10/2019
• 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: 61 YR
• Patient Sex: Male