MAUDE Adverse Event Report: BIOMET UK LTD. OXF TRL BRG W/SLOTS MED 3MM MM; KNEE PROSTHESIS

Catalog Number 32-422703

Device Problems Break (1069); Appropriate Term/Code Not Available (3191)

Patient Problems No Consequences Or Impact To Patient (2199); No Patient Involvement (2645)

Event Date 07/19/2018

Event Type  Injury  

Manufacturer Narrative

(b)(4).Report source, foreign - event occurred in (b)(6).The investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.

Event Description

Oxford trial bearing cracked while doing routine trial.Nothing fell into (b)(6).

Manufacturer Narrative

(b)(4).Device history record (dhr) was reviewed and no discrepancies were found.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

Oxford trial bearing cracked while doing routine trial.Nothing fell into patient.

Manufacturer Narrative

(b)(4).This follow-up report is being submitted to relay additional information.The complaint has been confirmed with visual inspection.The gouges and the burrs are observed close to the slot where the tibial bearing inserter/extractor attaches to the bearing.The damage indicates that an excessive force has been used to insert the trial bearing.The foot of the trial bearing has fractured.The most likely root cause of the fracture is mispositioning of the tibial bearing inserter.When the inserter is not engaged with the bearing properly, the forces are not distributed across the trial bearing, but rather applied on the thin foot of the bearing.Wear and tear over multiple uses and possible mispositioning of the tibial bearing inserter are the most likely causes of the fracture.However, the exact root cause cannot be established.The product was in the field for approximately 9 months.However, the exact number of uses cannot be determined from the information provided in the complaint.Device history record (dhr) was reviewed and no discrepancies were found.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

Oxford trial bearing cracked while doing routine trial.Nothing fell into patient.

• Brand Name: OXF TRL BRG W/SLOTS MED 3MM MM
• Type of Device: KNEE PROSTHESIS
• Manufacturer (Section D): BIOMET UK LTD.; waterton industrial estates; bridgend CF31 3XA; UK CF31 3XA
• MDR Report Key: 7789765
• MDR Text Key: 117718769
• Report Number: 3002806535-2018-01012
• Device Sequence Number: 1
• Product Code: NRA
• Combination Product (y/n): N
• PMA/PMN Number: PN/A
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,user facility
• Type of Report: Initial,Followup,Followup
• Report Date: 09/05/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/16/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 32-422703
• Device Lot Number: ZB170901
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 08/15/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: N/A
• Patient Sequence Number: 1