MAUDE Adverse Event Report: BIOMET UK LTD. DELTA CERAMIC FEM HD 36/0MM; BIOLOX DELTA CER FEM HD LG DIA

Model Number N/A

Device Problem Fracture (1260)

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

Event Date 06/03/2021

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Customer has indicated that the product will not be returned to zimmer biomet for investigation, as it has been discarded.The investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.Item discarded.

Event Description

It was reported that during initial surgery, the ceramic head fractured.

Manufacturer Narrative

(b)(4).This final report is being submitted to relay additional information.Complaint summary: as the product has not been received, 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 2 complaints reported with the item 650-0661 (including initiating complaint).Without the opportunity to examine the complaint product, root cause cannot be determined due to insufficient information.The supplied photograph confirms that the ceramic head item 650-0661 has fractured into several pieces but does not yield any information that could identify the cause.If any additional information becomes available, then the complaint will be reopened and investigated thoroughly.Capa: no corrective or preventive action required at this time.If any further information is found which would change or alter any conclusions or information, a supplemental will be submitted accordingly.Zimmer biomet will continue to monitor for trends.H3 other text: item discarded.

Event Description

It was reported that during initial surgery, the ceramic head fractured.

• Brand Name: DELTA CERAMIC FEM HD 36/0MM
• Type of Device: BIOLOX DELTA CER FEM HD LG DIA
• Manufacturer (Section D): BIOMET UK LTD.; waterton industrial estates; bridgend CF31 3XA; UK CF31 3XA
• MDR Report Key: 12038674
• MDR Text Key: 257507373
• Report Number: 3002806535-2021-00269
• Device Sequence Number: 1
• Product Code: OQG
• UDI-Device Identifier: 00887868271175
• UDI-Public: 00887868271175
• Combination Product (y/n): N
• PMA/PMN Number: K192683
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial,Followup
• Report Date: 06/29/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/22/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: N/A
• Device Catalogue Number: 650-0661
• Device Lot Number: 3030783
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 06/25/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: N/A
• Patient Sequence Number: 1
• Patient Outcome(s): Other