MAUDE Adverse Event Report: BIOMET UK LTD. CER BIOLOXD OPTION HD 36MM; HIP PROSTHESIS

Catalog Number	650-1057
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Pain (1994); Ambulation or Postural Difficulties (2544)
Date of Event	08/30/2023
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).D10 - associated medical devices: cer option type 1 tpr sleve -6; item# 650-1064; lot# 2912967.Tprlc 133 t1 pps ho 11x142mm; item# 51-104110; lot# 6232281.G7 finned 4 hole shell 56f; item# 110017105; lot# 6215509.G7 neutral e1 liner 36mm f; item# 010000858; lot# 6292613.Multiple mdr reports were filed for this event, please see associated reports: 3002806535-2024-00012.The device will not be returned for analysis; however, an investigation of the reported event is in progress.Once the investigation is completed, a supplemental medwatch 3500a will be submitted.
Event or Problem Description
It was reported that during a clinical study, at the 5-year follow-up appointment, the patient was experiencing pain, difficulty with ambulation and completing daily activities; and was diagnosed with tendonitis.The patient was treated with anti-inflammatory medication, physical therapy, and a steroid injection.The issue has been considered resolved.Due diligence is in progress for this complaint; to date no additional information or product has been received.
Additional Manufacturer Narrative
(b)(4).This follow-up report is being submitted to relay additional and corrected information.B3: the event date was corrected from (b)(6) 2023.If any further information is found which would change or alter any conclusions or information, a supplemental report will be filed accordingly.Zimmer biomet will continue to monitor for trends.
Event or Problem Description
It was reported that during a clinical study, at the 5-year follow-up appointment, the patient was experiencing pain, difficulty with ambulation and completing daily activities; and was diagnosed with tendonitis.The patient was treated with anti-inflammatory medication, physical therapy, and a steroid injection.The issue was considered resolved.Three-months later, in a follow-up appointment, the patient noted temporary relief from the injection but is still experiencing pain during active flexion or activity.The patient is maintaining conservative treatment modalities and physical therapy.Due diligence is in progress for this complaint; to date no additional information or product has been received.
Additional Manufacturer Narrative
(b)(4).This follow-up report is being submitted to relay additional and/or corrected information.Multiple mdr reports were filed for this event, please see associated report: 3002806535-2024-00012-2.The products remain implanted; therefore, visual and dimensional evaluations could not be performed.A review of the device manufacturing records confirmed no abnormalities or deviations.Radiographs were provided and reviewed by a radiologist.The review identified an anatomic alignment of the right hip arthroplasty without change in implant position from the 6 month post op through 5 year post op images.No cause for tendinitis is identified.Medical records were provided and reviewed by a health care professional.The review did not identify contributing factors of event.Patient received several cosrtisone injection but continues to have pain with active hip flexion which is alleviated with rest.Device is used for treatment.With the available information, a definitive root cause could not be determined.If any further information is found which would change or alter any conclusions or information, a supplemental report will be filed accordingly.Zimmer biomet will continue to monitor for trends.
Event or Problem Description
No further event information available at the time of this report.

• Brand Name: CER BIOLOXD OPTION HD 36MM
• Common Device Name: HIP PROSTHESIS
• 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: 18474588
• Report Number: 3002806535-2024-00011
• Device Sequence Number: 6775064
• Product Code: LZO
• UDI-Device Identifier: 00880304521957
• UDI-Public: (01)00880304521957(17)280312(10)2934974
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: K192683
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2018
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Study,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 03/06/2024

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: Lay User/Patient
• Device Catalogue Number: 650-1057
• Device Lot Number: 2934974
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/14/2023
• Supplement Date Received by Manufacturer: 01/17/2024; 02/29/2024
• Initial Report FDA Received Date: 01/09/2024
• Supplement Report FDA Received Date: 02/13/2024; 03/06/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 03/12/2018
• 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
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention; Hospitalization
• Patient Sex: Male
• Patient Weight: 98 KG
• Patient Race: Black Or African American