MAUDE Adverse Event Report: BIOMET UK LTD. DELTA CER FEM HD 32/-3MM T1; CERAMIC FEMORAL HEAD PROSTHESIS

Model Number N/A

Device Problem Insufficient Information (3190)

Patient Problems Unspecified Infection (1930); No Known Impact Or Consequence To Patient (2692)

Event Date 01/27/2020

Event Type  Injury  

Manufacturer Narrative

(b)(4).Report source, foreign country: event occurred in (b)(6).Customer has indicated that the product will not be returned to zimmer biomet for investigation, as it remains implanted.The investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.

Event Description

It was reported that the patient was admitted due to suspected wound infection (4 days admission).During the course of the hospital stay, the patient¿s lab results normalised without treatment or intervention.The patient was discharged.Attempts were made to retrieve additional information on the reported event, to date no additional information of product has been received.

Event Description

It was reported that the patient was admitted due to suspected wound infection (4 days admission).During the course of the hospital stay, the patient¿s lab results normalised without treatment or intervention.The patient was discharged with follow up scheduled.Attempts were made to retrieve additional information on the reported event, to date no additional information of product has been received.

Manufacturer Narrative

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

Event Description

It was reported that the patient was admitted due to suspected wound infection (4 days admission).During the course of the hospital stay, the patient¿s lab results normalised without treatment or intervention.The patient was discharged with follow up scheduled.

Manufacturer Narrative

(b)(4).As the product remains implanted in the patient, the investigation was limited to the information provided; a review of device history records and complaint history.In addition, we have not been provided with any supporting documentation which could provide additional information.A review of the manufacturing history records confirms no abnormalities or deviations reported.A review of the complaint database over the last 3 years has found no similar complaints reported with the item 650-1163.Without the opportunity to examine the complaint product, root cause cannot be determined due to insufficient information.If any additional information becomes available, then the complaint will be reopened and investigated thoroughly.

• Brand Name: DELTA CER FEM HD 32/-3MM T1
• Type of Device: CERAMIC FEMORAL HEAD PROSTHESIS
• Manufacturer (Section D): BIOMET UK LTD.; waterton industrial estates; bridgend CF31 3XA; UK CF31 3XA
• MDR Report Key: 9731466
• MDR Text Key: 180330257
• Report Number: 3002806535-2020-00090
• Device Sequence Number: 1
• Product Code: KXA
• Combination Product (y/n): N
• PMA/PMN Number: K131684
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup,Followup
• Report Date: 04/16/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/20/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: N/A
• Device Catalogue Number: 650-1163
• Device Lot Number: 2019090117
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 03/27/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: N/A
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization
• Patient Age: 73 YR
• Patient Weight: 86