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
Medical Device Problem Codes	Mechanical Problem (1384); Noise, Audible (3273)
Health Effect - Clinical Codes	Local Reaction (2035); Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available (4581)
Date of Event	08/17/2021
Type of Reportable Event	Serious Injury
Additional 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 or Problem 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 or Problem 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.
Additional 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 or Problem 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.
Additional 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
• Common Device Name: 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
• Report Number: 3002806535-2021-00441
• Device Sequence Number: 3473193
• Product Code: LZO
• UDI-Device Identifier: 00887868248474
• UDI-Public: 00887868248474
• Combination Product (Y/N): N
• Initial Reporter State: WA
• Initial Reporter Country: US
• PMA/510(K) Number: K061312
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Explanted Year: 2021
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 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
• Operator of Device: 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 Received by Manufacturer: 10/07/2021
• Supplement Date Received by Manufacturer: 10/28/2021; 12/23/2021
• Initial Report FDA Received Date: 10/12/2021
• Supplement Report FDA Received Date: 11/02/2021; 12/24/2021
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• If action reported to FDA under 21 USC 360i(g), list FDA-assigned Recall Number or include a statement: N/A
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: SEE H10 NARRATIVE.
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention
• Patient Sex: Male
• Patient Ethnicity: Non Hispanic
• Patient Race: White