MAUDE Adverse Event Report: BIOMET UK LTD. OXF CMNTLS IMPLANT INSERT; KNEE PROSTHESIS

Model Number N/A

Device Problem Break (1069)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 11/12/2019

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Report source, foreign - event occurred in (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 tibial impactor broke during routine impaction of tibial implant.The treading of the impactor cushion is loose which seems to affect instrument.Surgeon asked for a replacement.Nothing fell into patient.

Event Description

It was reported that the tibial impactor broke during routine impaction of tibial implant.The treading of the impactor cushion is loose which seems to affect instrument.Surgeon asked for a replacement.Nothing fell into patient.

Manufacturer Narrative

(b)(4).This final report is being submitted to relay additional information.G3: report source, foreign - event occurred in canada.Products have been returned to biomet uk ltd for evaluation and forwarded to the product evaluation complaints engineer for investigation.The event reports that the cushion pad is missing from the instrument.This event occurred during surgery.No harm was reported.The complaint has been confirmed following review of the returned instrument, which confirms the cushion pad is missing.The instrument should have a total of two cushion pads assembled, but only one cushion pad is present.A review of the device history records did not identify any discrepancies that would have contributed to the reported event.A complaint history review identified 32 similar complaints for the same item number since the instrument was released.A complaint history review identified no similar complaints for the same lot number.The reported event is covered cemented oxford partial knee system-risk management report and cemented oxford partial knee system implant.The severity of the reported event is in line with this risk file.The occurrence rate for all similar events is also in line with the risk file.The rpn is low risk.This device is used for treatment.The reported event is not related to a combination of products; therefore, a compatibility review is not applicable.The reusable instrument lifespan manual states that instruments should be inspected for completeness and function during reprocessing.The oxford partial knee microplasty instrumentation assembly/disassembly document instructs not to disassemble the cementless impactor for reprocessing.The likely condition of the device when it left zimmer biomet is conforming to specification.The likely cause of the reported event is the cushion pads were incorrectly removed for cleaning (the oxford partial knee miscroplasty instrumentation assemble/disassembly instructions clearly state not to disassemble the cementless impactor)n, and was also not adequately inspected before sterilisation, as instructed in the reusable instrument lifespan manual.No corrective action required at this time.Both the severity and occurrence of the reported event are in line with the risk file.No harm beyond extension to surgery time, minor, has been reported.The item was distributed conforming.Adequate instructions are provided to ensure the instrument is reprocessed correctly.Corrective action taken: -no corrective action required at this time.Both the severity and occurrence of the reported event are in line with the risk file.-no harm beyond extension to surgery time, minor, has been reported.-the item was distributed conforming.Adequate instructions are provided to ensure the instrument is reprocessed correctly.Preventive action taken: no preventative action required at this time.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 CMNTLS IMPLANT INSERT
• Type of Device: KNEE PROSTHESIS
• Manufacturer (Section D): BIOMET UK LTD.; waterton industrial estates; bridgend CF31 3XA; UK CF31 3XA
• MDR Report Key: 9415204
• MDR Text Key: 189900805
• Report Number: 3002806535-2019-00907
• 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: foreign,health professional
• Type of Report: Initial,Followup
• Report Date: 06/10/2020

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: 32-422097
• Device Lot Number: ZB161003
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/13/2020
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 11/13/2019
• Initial Date FDA Received: 12/05/2019
• Supplement Dates Manufacturer Received: 06/08/2020
• Supplement Dates FDA Received: 06/10/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: N/A
• Patient Sequence Number: 1