MAUDE Adverse Event Report: BIOMET UK LTD. CER BIOLOXD MOD HD 36MM -3 NK; BIOLOX DELTA CER OPT HD LG DIA

Model Number N/A

Device Problems Mechanical Problem (1384); Noise, Audible (3273)

Patient Problems Local Reaction (2035); Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)

Event Date 08/17/2021

Event Type  Injury  

Manufacturer Narrative

(b)(4).Initial report.Concomitant medical products: customer has indicated that the product will not be returned to zimmer biomet for investigation, due to hospital policy.The investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.

Event Description

It was report that the patient was experiencing impingement and or a clicking in his hip.Patient claimed that his hip was dislocating in mid flexion with leg extended.The patient had several x-rays, ultra sound visits and nothing showed to be dislocated.Implants were in good positions an acceptable version was used.During pre op the surgeon went through several range of motion tests and the hip did not dislocate, but there was a small click which the surgeon determined was tightness in the it band.Patient was revised on (b)(6) 2021.

Event Description

It was report that the patient was experiencing impingement and or a clicking in his hip.Patient claimed that his hip was dislocating in mid flexion with leg extended.The patient had several x-rays, ultra sound visits and nothing showed to be dislocated.Implants were in good positions an acceptable version was used.During pre op the surgeon went through several range of motion tests and the hip did not dislocate, but there was a small click which the surgeon determined was tightness in the it band.Patient was revised on (b)(6), 2021.

Manufacturer Narrative

(b)(4).This follow-up report is being submitted to relay additional information.Patient's initials: (b)(6).Gender: male.Race: caucasian.Associated item number #(b)(4), item name g7 neutral e1 liner 36mm f, lot # 6455575.The investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.

Event Description

It was report that: the patient was experiencing impingement and or a clicking in his hip.Patient claimed that his hip was dislocating in mid flexion with leg extended.The patient had several x-rays, ultra sound visits and nothing showed to be dislocated.Implants were in good positions an acceptable version was used.During pre op the surgeon went through several range of motion tests and the hip did not dislocate, but there was a small click which the surgeon determined was tightness in the it band.Patient was revised on (b)(6) 2021.Patient involvement.

Manufacturer Narrative

(b)(4).This final report is being submitted to relay additional information.Complaint summary: implants were in good positions, an acceptable version was used.During pre op the surgeon went through several range of motion tests and the hip did not dislocate, but there was a small click which the surgeon determined was tightness in the it band.Patient was revised on (b)(6) 2021.Patient involvement.The investigation was limited to a review of the complaint history as the reported product was not returned, no x-rays of the reported event or dhr were made available for review.Review of complaint history identified no additional similar complaints for the reported item number in the last 3 years and no additional complaints for the same item and lot combination.It has been confirmed that the item is not within the scope or subject of any field actions or recalls which could be attributed to reported event.Without the opportunity to examine the complaint product, a definitive root cause cannot be determined due to insufficient information.The risk associated with the reported event has a severity score of 3 as surgical intervention was required and an occurrence rate of 2 (remote, greater than 1 in 10,000 and less than 1 in 100,000) the severity and occurrence rate of the reported event is deemed to be in line with the risk file.The risk is deemed to be low.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.

• Brand Name: CER BIOLOXD MOD HD 36MM -3 NK
• Type of Device: BIOLOX DELTA CER OPT HD LG DIA
• 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: 12613154
• MDR Text Key: 275879908
• Report Number: 3002806535-2021-00441
• Device Sequence Number: 1
• Product Code: LZO
• UDI-Device Identifier: 00887868248474
• UDI-Public: 00887868248474
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K061312
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date: 12/24/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: N/A
• Device Catalogue Number: 12-115120
• Device Lot Number: 2968719
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 10/07/2021
• Initial Date FDA Received: 10/12/2021
• Supplement Dates Manufacturer Received: 10/28/2021; 12/23/2021
• Supplement Dates FDA Received: 11/02/2021; 12/24/2021
• Was Device Evaluated by Manufacturer?: Yes
• 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
• Treatment: SEE H10 NARRATIVE.
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Sex: Male
• Patient Ethnicity: Non Hispanic
• Patient Race: White