MAUDE Adverse Event Report: BIOMET UK LTD. OXF UNI CMNTLS TIB SZ E LM; KNEE PROSTHESIS

Model Number N/A

Device Problem Fitting Problem (2183)

Patient Problems No Consequences Or Impact To Patient (2199); No Code Available (3191)

Event Date 12/11/2019

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Foreign report source: (b)(6).Customer has indicated that the product is in the process of being returned to zimmer biomet for investigation.Once the investigation is complete, a supplemental mdr will be submitted.The investigation is in process.Once the investigation is complete, a follow-up mdr will be submitted.

Event Description

It was reported that the surgeon went to implant a cementless oxford tibia and the implant wouldn't seat correctly.This could be due to the keel blade not fully flush during tibial prep.

Manufacturer Narrative

(b)(4).This final report is being submitted to relay additional information.G3: report source, foreign - event occurred in united kingdom.Patient information is not allowed by country regulations.Products have been returned to biomet uk ltd for evaluation and forwarded to the complaints processing unit for investigation.The event reports that the surgeon went to implant a cementless oxford tibia and the implant would not seat.He thought this could be due to the keel blade not fully flush during tibial prep but also queried if the coating on the tibial implant keel was too thick.Visual inspection confirmed the identity of the returned product.There were no visual abnormalities that could be related to the reported event.The keel dimension was checked according to the inspection criteria q000122.The keel was conforming to design specifications.The complaint has not been confirmed following review of the returned implant, which confirmed the device is conforming to specification.The reported event of incorrect keel thickness has not been substantiated, therefore root cause cannot be determined.The product left zimmer biomet control conforming.Medical records or x-rays are not required.Issue applies to product dimensions.No corrective or preventative actions needed at this time.It has been determined that this complaint is not a new confirmed quality or manufacturing issue.Complaints are monitored through monthly complaint reviews in order to identify potential adverse trends.A review of the complaint database has found no similar complaints reported with this item # / lot # combination.A review of the complaints data base for 3 years prior to the notification date has found no similar reported events for this item.The mhr related to the involved product has been reviewed and does not show any non-conformity, rejection or concession that could be related to the reported event.All the lot (12 units) was accepted at the time of manufacturing.Risk assessment: this event occurred during surgery.No further harm or procedural delay was reported.The actual severity score is in line with the risk file.Occurrence rate assessment: an occurrence assessment is not required as the reported event has not been confirmed, therefore does not meet the criteria for occurrence rate assessment.Risk score: risk score not required at the reported event has not been confirmed.The hazard and reported harm are covered by the risk file are within acceptable limits.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.

Event Description

It was reported that the surgeon went to implant a cementless oxford tibia and the implant wouldn't seat.Surgeon thought that this could be due to the keel blade not fully flush during tibial preparation.

• Brand Name: OXF UNI CMNTLS TIB SZ E LM
• Type of Device: KNEE PROSTHESIS
• Manufacturer (Section D): BIOMET UK LTD.; waterton industrial estates; bridgend CF31 3XA; UK CF31 3XA
• MDR Report Key: 9486345
• MDR Text Key: 214804929
• Report Number: 3002806535-2019-00932
• 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: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 07/07/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/18/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: N/A
• Device Catalogue Number: 166578
• Device Lot Number: 6325460
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/19/2020
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 06/30/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: N/A
• Patient Sequence Number: 1