MAUDE Adverse Event Report: BIOMET UK LTD. OXF TWIN PEG CMNTLS FMRL LG; KNEE PROSTHESIS

Model Number N/A

Device Problem Loose or Intermittent Connection (1371)

Patient Problem No Information (3190)

Event Date 03/24/2019

Event Type  Injury  

Manufacturer Narrative

(b)(4).Customer has indicated that the product is in process of being returned to zimmer biomet for investigation.Once the investigation has been completed, a supplemental mdr will be submitted.Concomitant medical products: medical product: oxf anat brg lt lg size 4 pma.Catalog #:159555 , lot #: 473010, medical product: oxford cementless tibia f lm.Catalog #:us166580 , lot #: r3058145a.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 a patient underwent an initial left knee procedure.Subsequently, the patient was revised to total knee due to loosening of femoral component.

Event Description

It was reported by the hospital that a patient underwent an initial left knee procedure.Subsequently, the patient was revised to total knee due to loosening of femoral component.

Manufacturer Narrative

(b)(4).Reported event was confirmed by review of x-rays provided.Device history record (dhr) was reviewed and no discrepancies were found.Root cause was unable to be determined as the necessary information to adequately investigate the reported event was not provided.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.

Manufacturer Narrative

(b)(4).This complaint is a duplicate of (b)(4).

Event Description

This complaint is a duplicate of (b)(4).

• Brand Name: OXF TWIN PEG CMNTLS FMRL LG
• Type of Device: KNEE PROSTHESIS
• Manufacturer (Section D): BIOMET UK LTD.; waterton industrial estates; bridgend CF31 3XA; UK CF31 3XA
• MDR Report Key: 8690732
• MDR Text Key: 147708336
• Report Number: 3002806535-2019-00499
• 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: health professional
• Type of Report: Initial,Followup,Followup
• Report Date: 08/22/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/12/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: N/A
• Device Catalogue Number: 161475
• Device Lot Number: R3050588A
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 08/21/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: N/A
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Weight: 84