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

Catalog Number 161469

Device Problems Device-Device Incompatibility (2919); Insufficient Information (3190)

Patient Problem Pain (1994)

Event Date 02/22/2017

Event Type  Injury  

Manufacturer Narrative

(b)(4).The investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.

Event Description

Patient¿s legal counsel reported patient underwent right knee arthroplasty.Legal counsel further reports patient underwent a revision procedure due to patient allegations of pain.

Event Description

Patient¿s legal counsel reported patient underwent right knee arthroplasty.Legal counsel further reports patient underwent a revision procedure due to patient allegations of pain.

Manufacturer Narrative

(b)(4).This follow-up report is being submitted to relay additional information.Review of the reported components for compatibility determined that the reported products are considered incompatible and are not cleared for use.Device history record (dhr) was reviewed and no discrepancies were found.Disease progression, usage of incompatible devices, rupturing of the patellar tendons, overhanging implants can all contribute to patient's pain.However, a definitive root cause cannot be determined.If any further information is found which would change or alter any conclusions or information, a supplemental will be filed accordingly.Zimmer biomet will continue to monitor for trends.

• Brand Name: OXF TWIN-PEG CMNTD FEM MD PMA
• Type of Device: KNEE PROSTHESIS
• Manufacturer (Section D): BIOMET UK LTD.; waterton industrial estates; bridgend CF31 3XA; UK CF31 3XA
• MDR Report Key: 7846085
• MDR Text Key: 119223411
• Report Number: 3002806535-2018-01058
• Device Sequence Number: 1
• Product Code: NRA
• Combination Product (y/n): N
• PMA/PMN Number: P010014
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: other
• Type of Report: Initial,Followup
• Report Date: 01/31/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/05/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: 161469
• Device Lot Number: 60
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 01/09/2019
• 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
• Patient Age: 39 YR