MAUDE Adverse Event Report: BIOMET UK LTD. CER BIOLOXD OPTION HD 28MM; HIP ARTHROPLASTY

Model Number N/A

Device Problem Physical Resistance/Sticking (4012)

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

Event Date 10/13/2021

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Initial report.Concomitant medical products: customer has indicated that the product will not be returned to zimmer biomet for investigation.Associated products: medical product: e1 ringloc bipolar 28x44mm, catalog no.: 110010461, lot no.: 720060.The investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.

Event Description

The customer reported that he incorporated a delta ceramic head (650-1055) into a e1 bipolar liner, but the head did not move.Surgery time was extended by 1 to 3 minutes.

Manufacturer Narrative

(b)(4).This final report is being submitted to relay additional information.No product was returned or pictures provided; visual and dimensional evaluations could not be performed.This device is used for treatment.No compatibility issues were noted.Review of the device history records identified no related deviations or anomalies during manufacturing related to the reported event.A review of complaint history was assessed for three years prior to the notification date and identified (4) similar complaints for item 650-1055 (including initiating complaint).There were (0) additional complaints against the lot 3063466.Without the opportunity to examine the complaint product, root cause cannot be determined.No corrective actions, preventive actions, or field actions resulted after investigation of this event.

Event Description

The customer reported that he incorporated a delta ceramic head (650-1055) into a e1 bipolar liner, but the head did not move.Surgery time was extended by 1 to 3 minutes.

• Brand Name: CER BIOLOXD OPTION HD 28MM
• Type of Device: HIP ARTHROPLASTY
• 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: 12744605
• MDR Text Key: 279821600
• Report Number: 3002806535-2021-00480
• Device Sequence Number: 1
• Product Code: LZO
• UDI-Device Identifier: 00887868271373
• UDI-Public: 00887868271373
• 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: 01/14/2022

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: 650-1055
• Device Lot Number: 3063466
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 10/21/2021
• Initial Date FDA Received: 11/03/2021
• Supplement Dates Manufacturer Received: 01/14/2022
• Supplement Dates FDA Received: 01/14/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 03/29/2021
• 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