MAUDE Adverse Event Report: BIOMET UK LTD. OXFORD PH3 CEMENTLESS FEM SZ M; PROSTHESIS, KNEE, FEMOROTIBIAL, UNICOMPARTMENTAL, SEMI-CONSTRAINED

Catalog Number 154926

Device Problem Scratched Material (3020)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 08/07/2023

Event Type  malfunction  

Manufacturer Narrative

(b)(4).G2-foreign- australia.Investigation of this incident is currently ongoing.Once the investigation is completed, a supplemental medwatch 3500a will be submitted.

Event Description

It was reported that when surgeon removed the implant from the inner packaging, a scratch was observed on the articulating surface of the femoral implant.The procedure was completed with a new femoral implant.Due diligence is in progress for this complaint; to date, whatever additional information received has been included in this report.

Manufacturer Narrative

(b)(4).This follow-up report is being submitted to relay additional information.Visual examination of the returned product identified that the device was returned with no shrink film and a scratch on the outside of the product carton that did not penetrate the secondary carton.The product was returned loose in the cavity without the tyvek lid and a piece of foam and fabric.There is a scratch on the articulate surface of the femoral.No other apparent damage to the device.A review of the device manufacturing records confirmed no abnormalities or deviations.Device is used for treatment.Medical records were not provided.With the available information, a definitive root cause could not be determined.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

No further event information available at the time of this report.

• Brand Name: OXFORD PH3 CEMENTLESS FEM SZ M
• Type of Device: PROSTHESIS, KNEE, FEMOROTIBIAL, UNICOMPARTMENTAL, SEMI-CONSTRAINED
• 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: 17675822
• MDR Text Key: 322639599
• Report Number: 3002806535-2023-00296
• Device Sequence Number: 1
• Product Code: NRA
• UDI-Device Identifier: 00887868353772
• UDI-Public: (01)00887868353772(17)330409(10)7463518
• Combination Product (y/n): N
• Reporter Country Code: AS
• PMA/PMN Number: P010014
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 12/27/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/04/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 154926
• Device Lot Number: 7463518
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 12/14/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/09/2023
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Sex: Female