MAUDE Adverse Event Report: BIOMET UK LTD. OXF ANAT BRG RT MD SIZE 4 PMA MED SZ 4; KNEE PROSTHESIS

Model Number N/A

Device Problem Device Markings/Labelling Problem (2911)

Patient Problem No Information (3190)

Event Date 03/05/2019

Event Type  Injury  

Manufacturer Narrative

(b)(4).Unique identifier (udi) number: (b)(4).Report source, foreign - event occurred in the (b)(6).Customer has indicated that the product is in process of being 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 by the hospital that during a knee replacement procedure an incorrect product was found in the packaging.The box was labelled: 159576 oxford anatomical bearing medium right 4mm, lot 6461000, exp 15/01/2024, however, the implant found in the box was medium left 4mm, lot 6461000.As a result, a 3mm bearing was used instead as there was no medium right 4mm bearing available.

Manufacturer Narrative

(b)(4).This follow-up report is being submitted to relay additional information.The following sections were updated: b4, b5, g4, g7, h1, h2, h3, h6, h7, h9, h10.A visual inspection confirmed the reported event and revealed that a left handed bearing had been supplied within the package labeled for a right handed bearing.Device history record (dhr) was reviewed and no discrepancies were found.The root cause of the reported event is attributed to a manufacturing issue.

Event Description

It was reported by the hospital that during a knee replacement procedure an incorrect product was found in the packaging.The box was labelled: 159576 oxford anatomical bearing medium right 4mm lot 6461000 exp 15/01/2024, however, the implant found in the box was medium left 4mm, lot 6461000.As a result, a 3mm bearing was used instead as there was no medium right 4mm bearing available.

• Brand Name: OXF ANAT BRG RT MD SIZE 4 PMA MED SZ 4
• Type of Device: KNEE PROSTHESIS
• Manufacturer (Section D): BIOMET UK LTD.; waterton industrial estates; bridgend CF31 3XA; UK CF31 3XA
• MDR Report Key: 8477117
• MDR Text Key: 146541284
• Report Number: 3002806535-2019-00337
• 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
• Remedial Action: Recall
• Type of Report: Initial,Followup
• Report Date: 09/11/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/03/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 01/15/2024
• Device Model Number: N/A
• Device Catalogue Number: 159576
• Device Lot Number: 6461000
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 08/12/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: ZFA 2019-00113
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention