MAUDE Adverse Event Report: BIOMET UK LTD. BIOLOX DELTA HEAD, 28MM +3.5MM NECK, 12/14 TAPER; HIP PROSTHESIS

Model Number N/A

Device Problem Off-Label Use (1494)

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

Event Date 06/20/2022

Event Type  Injury  

Manufacturer Narrative

(b)(4).Source foreign: italy.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 expired product has been implanted.No known impact to the patient.Due diligence is in progress for this complaint; to date no additional information or product has been received.

Event Description

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

Manufacturer Narrative

(b)(4).This follow-up report is being submitted to relay additional information.No product was returned or pictures provided; visual and dimensional evaluations could not be performed.Review of the device history record identified no deviations or anomalies during manufacturing.Device is used for treatment.Sterile cert reviewed and confirms product was irradiated in conformance with technical agreement.Medical records were not provided.The likely condition of the device when it left zimmer biomet is conforming to specification.The definitive root cause of the reported event cannot be determined with the information provided, however user error is likely to have contributed to the reported event.If any further information is found which would change or alter any conclusions or information, a supplemental report will be filed accordingly.Zimmer biomet will continue to monitor for trends.

• Brand Name: BIOLOX DELTA HEAD, 28MM +3.5MM NECK, 12/14 TAPER
• Type of Device: HIP 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: 15025898
• MDR Text Key: 295954885
• Report Number: 3002806535-2022-00307
• Device Sequence Number: 1
• Product Code: LZO
• UDI-Device Identifier: 05019279116881
• UDI-Public: (01)05019279116881(17)220619(11)2732825
• Combination Product (y/n): N
• Reporter Country Code: IT
• PMA/PMN Number: N/A
• 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: 08/11/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/15/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 06/19/2022
• Device Model Number: N/A
• Device Catalogue Number: 650-0832
• Device Lot Number: 2732825
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 07/29/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 01/03/2016
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Removal/Correction Number: N/A
• Patient Sequence Number: 1
• Patient Outcome(s): Other