MAUDE Adverse Event Report: BIOMET UK LTD. OXF ANAT BRG RT MD SIZE 3 PMA; KNEE PROSTHESIS

Model Number N/A

Device Problem Product Quality Problem (1506)

Patient Problems No Patient Involvement (2645); No Known Impact Or Consequence To Patient (2692)

Event Date 12/18/2019

Event Type  malfunction  

Manufacturer Narrative

(b)(4).The product had been returned to zimmer biomet for investigation.The investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.

Event Description

It was reported that there were streaks and scuffs in the poly of an oxford bearing.Another device was used to complete the procedure.There was no delay in the procedure and did not cause any serious injury.

Manufacturer Narrative

(b)(4).This final report is being submitted to relay additional information.The following sections were updated: b4, b5, g4, h1, h2, h3, h6, h10.The product has returned to biomet uk ltd for evaluation.The mhr does not show any non-conformity, rejection or concession that could be related to the reported event.There are no surface scratches on the bearing.The instrument inspection results are detailed in the ifu.The part has passed all quality checks.The most likely condition the implant left manufacturing site is conforming.No corrective actions have been initiated, since no design or manufacturing deficiencies have been identified.No other complaint shave been reported against the item 159575 and 543390 lot combination.In addition, no further complaints were found reported against the item number (159575).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 there were streaks and scuffs in the poly of an oxford bearing.Another device was used to complete the procedure.There was no delay in the procedure and did not cause any serious injury.

• Brand Name: OXF ANAT BRG RT MD SIZE 3 PMA
• Type of Device: KNEE PROSTHESIS
• Manufacturer (Section D): BIOMET UK LTD.; waterton industrial estates; bridgend CF31 3XA; UK CF31 3XA
• MDR Report Key: 9590884
• MDR Text Key: 196070282
• Report Number: 3002806535-2020-00024
• Device Sequence Number: 1
• Product Code: NRA
• UDI-Device Identifier: 05019279786213
• UDI-Public: 05019279786213
• 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,health
• Type of Report: Initial,Followup
• Report Date: 02/28/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• 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: 159575
• Device Lot Number: 543390
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/26/2019
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 12/19/2019
• Initial Date FDA Received: 01/15/2020
• Supplement Dates Manufacturer Received: 02/21/2020
• Supplement Dates FDA Received: 02/28/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: N/A
• Patient Sequence Number: 1
• Patient Outcome(s): Other