MAUDE Adverse Event Report: BIOMET UK LTD. OXF TWIN-PEG CMNTD FEM SM PMA; KNEE PROTHESIS

Model Number N/A

Device Problem Patient Device Interaction Problem (4001)

Patient Problem Insufficient Information (4580)

Event Date 10/20/2021

Event Type  Injury  

Manufacturer Narrative

(b)(4).Initial report.Customer has indicated that the product will not be returned to zimmer biomet for investigation.Multiple mdr reports were filed for this event, please see associated reports: 3002806535-2021-00462, 3002806535-2021-00463.The investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.Not returned by patient.

Event Description

It was reported that a patient underwent an initial left knee arthroplasty on an unknown date.Subsequently, a revision procedure due to unknown reasons was performed on (b)(6) 2021 when the patient was converted to a total knee.

Manufacturer Narrative

(b)(4) this final report is being submitted to relay additional information.The following sections were updated: b4, b5, g3, g6, h1, h2, h3, h6, h10.Complaint summary: 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.These devices are 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 devices when 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 required at this time as the root cause of the reported event has not been determined.Multiple mdr reports were filed for this event, please see associated reports: 3002806535-2021-00462-1 3002806535-2021-00463-1 the investigation is completed based on current available information.If any additional information becomes available, then the complaint will be reopened and further investigated.Not returned by patient.

Event Description

It was reported that a patient underwent an initial left knee arthroplasty on an unknown date.Subsequently, a revision procedure due to unknown reasons was performed on (b)(6) 2021 when the patient was converted to a total knee.

Manufacturer Narrative

(b)(4).This follow-up final report is being submitted to relay additional information.Reason for revision and product numbers have been provided.D10: medical product: oxf anat brg lt sm size 4 pma, catalog #: 159541, lot #:922070 medical product: oxf uni tib tray sz b lm pma, catalog #: 154720, lot #: 381600 multiple mdr reports were filed for this event, please see associated reports: 3002806535-2021-00462-2, 3002806535-2021-00463-2.Product has not been returned for evaluation, and x-rays or medical notes have not been provided.Therefore, the investigation has been limited to the information provided, a review of the device history records, and a complaint history search.Review of the device history records identified no deviations or anomalies during manufacturing that could be related to the reported event.A review of the complaints database for 3 years prior to the notification date has identified the following information: three (3) similar complaints about item #159541 (including the initiating complaint).There were zero (0) additional complaints against lot #922070.Three (3) similar complaints about item #154720 (including the initiating complaint).There were zero (0) additional complaints against lot #381600.Thirteen (13) similar complaints about item #161468 (including the initiating complaint).There were zero (0) additional complaints against lot #315410.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 specification.The root cause of the reported event is likely to be disease progression, which is not considered device related.No corrective action required at this time as the root cause of the reported event is not device related.

Event Description

It was reported that a patient underwent an initial left knee arthroplasty on (b)(6) 2016.Subsequently, a revision procedure due to disease progression was performed on (b)(6) 2021 when the patient was converted to a total knee.

• Brand Name: OXF TWIN-PEG CMNTD FEM SM PMA
• Type of Device: KNEE PROTHESIS
• 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: 12687883
• MDR Text Key: 278077560
• Report Number: 3002806535-2021-00464
• Device Sequence Number: 1
• Product Code: NRA
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P01004
• 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,Followup
• Report Date: 02/04/2022

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: 315410
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 10/20/2021
• Initial Date FDA Received: 10/25/2021
• Supplement Dates Manufacturer Received: 01/26/2022; 01/27/2022
• Supplement Dates FDA Received: 01/26/2022; 02/04/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 05/27/2016
• 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: SEE H10 COMMENT
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 68 YR
• Patient Sex: Female