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 Mechanical Problem (1384); Physical Resistance/Sticking (4012)

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

Event Date 12/27/2021

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Initial report.Report source, foreign - event occurred in (b)(6).Customer has indicated that the product is in process of being returned to zimmer biomet for investigation.Concomitant medical products: medical product: e1 ringloc bipolar 28x44mm.Catalog no.: 110010461.Lot no.: 395170.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 head was stuck hard in the e1 liner.Delay: 0-15 minutes, it took a few minutes to replace the same product.Patient outcome: prolonged surgery.

Event Description

It was reported, that the head was stuck hard in the e1 liner.Delay: 0-15 minutes, it took a few minutes to replace the same product.Patient outcome: prolonged surgery.

Manufacturer Narrative

(b)(4).This final report is being submitted to relay additional information.Complaint summary: a visual inspection shows the surface of the sphere to be in good condition with no damage, the internal taper has circular rings consistent with the head being assembled with the femoral stem.A dimensional inspection was conducted and the delta ceramic femoral head was found to be conforming to specification.Review of the device history records identified no deviations or anomalies during manufacturing that could be related to the reported event.Review of complaint history identified 3 additional similar complaints for the reported item and no additional complaints for the reported item and lot combination.This device is used for treatment.The reported products were reviewed for compatibility with no issues noted.It has been confirmed that the implant is not within the scope or subject of any field actions or recalls which could be attributed to reported event.The likely condition of the device when it left zimmer biomet is conforming to specification.The reported event has not been confirmed as the dimensional inspect shows the product is conforming to specification and the dhr review did not identify any issues.The root cause of the reported event cannot be determined with the information provided.

• 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: 13287974
• MDR Text Key: 284173603
• Report Number: 3002806535-2022-00012
• 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: 03/31/2022

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: 3079921
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 01/06/2022
• Initial Date FDA Received: 01/19/2022
• Supplement Dates Manufacturer Received: 03/31/2022
• Supplement Dates FDA Received: 03/31/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/04/2021
• 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