MAUDE Adverse Event Report: BIOMET UK LTD. DELTA CER FEM HD 28/0MM T1; BIOLOX DELTA CERAMIC FEM HD

Model Number N/A

Device Problems Difficult to Insert (1316); Activation, Positioning or Separation Problem (2906); Positioning Problem (3009)

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

Event Date 11/10/2021

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Initial report.(b)(6).Customer has indicated that the product will not be returned to zimmer biomet for investigation.Medical product: e1 ringloc bipolar 28x47mm, catalog no.: 110010459, lot no.: 642620.The investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.Device not returned.

Event Description

It was reported that the delta ceramic head was located into the e1 bipolar liner, but the ceramic head would not articulate in the liner.Surgery time was extended by 1 to 3 minutes.

Manufacturer Narrative

(b)(4).This final report is being submitted to relay additional information.The following sections were updated: b4, b5, g3, g6, h1, h2, h3, h6, h10.Complaint summary: a physical visual inspection of the delta ceramic femoral head 28/0mm t1 (item: 650-1158 lot: 3069861) could not be carried out as the product has not been returned to the uk.But a review of the photographs taken and attached in associated complaint cmp-0753554 shows the spherical diameter to be in good condition with no visible defects, the internal taper has some metallic marks most likely caused by the assembly onto to hip stem.A dimensional inspection has been carried out and delta ceramic femoral head 28/0mm t1 (item: 650-1158 lot: 3069861) was found to be conforming to drawing specification, see attached inspection form.The root cause cannot be confirmed for the reported event as delta ceramic femoral head 28/0mm t1 (item: 650-1158 lot: 3069861) is conforming to specification.Investigation is completed based on current available information.If any additional information becomes available, then the complaint will be reopened and investigated.The product left zb control conforming to specification.A review of the complaints database shows that we have received 3 reported events for implant would not assemble with mating implant for the same item number 650-1158 prior to the reported event.The severity associated with the above line is unknown as the product is conforming and the definitive root cause has not been established.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.See h10.

Event Description

It was reported, that: delta ceramic head into the e1 bipolar liner, but the ceramic head did not move in the e1 bipolar liner.I want to know what is happened for these issue.Patient outcome: prolonged surgery.

• Brand Name: DELTA CER FEM HD 28/0MM T1
• Type of Device: BIOLOX DELTA CERAMIC FEM HD
• 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: 12868879
• MDR Text Key: 281203717
• Report Number: 3002806535-2021-00509
• Device Sequence Number: 1
• Product Code: LZO
• UDI-Device Identifier: 00887868271526
• UDI-Public: 00887868271526
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K192683
• 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: 01/11/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• 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: 650-1158
• Device Lot Number: 3069861
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 11/17/2021
• Initial Date FDA Received: 11/24/2021
• Supplement Dates Manufacturer Received: 01/04/2022
• Supplement Dates FDA Received: 01/11/2022
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 05/25/2021
• 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