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

Catalog Number 650-1057

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Inflammation (1932); Pain (1994); Loss of Range of Motion (2032)

Event Date 03/14/2023

Event Type  Injury  

Manufacturer Narrative

(b)(4).D10 - associated medical devices: cer option type 1 tpr sleve -3; item# 650-1065; lot# 329700.Tprlc 133 type1 pps so 9x137mm; item# 51-103090, lot# 3880920.G7 finned 3 hole shell 52e; item# 110017103; lot# 384140.7 g7 neutral e1 liner 36mm e; item# 010000857; lot# 3915013.Multiple mdr reports were filed for this event, please see associated reports: 3002806535-2024-00016.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 Description

It was reported that the patient began to experience moderate pain with a decrease in range of motion approximately 6 years post-implantation.The patient received cortisone injections for right inguinal pain, exacerbated with active hip flexion.The cortisone injections alleviated the pain for three weeks but is now reporting severe pain.No definitive planned intervention has been reported.Due diligence is in progress for this complaint; to date no additional information or product has been received.

Manufacturer Narrative

(b)(4).This follow-up report is being submitted to relay additional and/or corrected information.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.Devices are used for treatment.Medical records were provided and reviewed by a health care professional.The review identified normal rom, leg lengths were equal, anterior right hip pain ad inflammation with flexion and internal /external rotation.Surgeon discussed option of downsizing cup.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 Description

No further event information available at the time of this report.

• Brand Name: CER BIOLOXD OPTION HD 36MM
• Type of Device: 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: 18481991
• MDR Text Key: 332490900
• Report Number: 3002806535-2024-00015
• Device Sequence Number: 1
• Product Code: LZO
• UDI-Device Identifier: 00880304521957
• UDI-Public: (01)00880304521957(17)261217(10)537390
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K200959
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Study,Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 02/12/2024

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
• Device Operator: Lay User/Patient
• Device Catalogue Number: 650-1057
• Device Lot Number: 537390
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 12/14/2023
• Initial Date FDA Received: 01/10/2024
• Supplement Dates Manufacturer Received: 01/18/2024
• Supplement Dates FDA Received: 02/13/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 12/17/2016
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Sex: Female
• Patient Weight: 86 KG
• Patient Race: White