MAUDE Adverse Event Report: BIOMET UK LTD. OXFORD PH3 CEMENTLESS FEM SZ L; KNEE PROSTHESIS

Catalog Number 154927

Device Problem Loss of or Failure to Bond (1068)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Type  Injury  

Manufacturer Narrative

(b)(4).Report source, foreign - event occurred in (b)(6).Udi: (b)(4).Customer has indicated that the product is available for return to zimmer biomet for investigation.Once the investigation has been completed, a follow-up mdr will be submitted.

Event Description

It was reported that the patient had a revision due to loosening.

Manufacturer Narrative

(b)(4).This follow-up report is being submitted to relay additional information.The following sections were updated.Reported event was unable to be confirmed due to limited information received from customer.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.

• Brand Name: OXFORD PH3 CEMENTLESS FEM SZ L
• Type of Device: KNEE PROSTHESIS
• Manufacturer (Section D): BIOMET UK LTD.; waterton industrial estates; bridgend CF31 3XA; UK CF31 3XA
• Manufacturer (Section G): BIOMET UK LTD.; waterton industrial estates; bridgend CF31 3XA; UK CF31 3XA
• Manufacturer Contact: christina arnt ; 56 e. bell dr.; warsaw, IN 46582 ; 5745273773
• MDR Report Key: 7164612
• MDR Text Key: 96381539
• Report Number: 3002806535-2017-01250
• Device Sequence Number: 1
• Product Code: NRA
• Combination Product (y/n): N
• Reporter Country Code: UK
• PMA/PMN Number: PN/A
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 06/20/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/04/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: No Information
• Device Catalogue Number: 154927
• Device Lot Number: 3841258
• Other Device ID Number: SEE H10
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 06/20/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 08/05/2016
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Removal/Correction Number: N/A
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention