MAUDE Adverse Event Report: BIOMET UK LTD. BIOLOX DELTA MODULAR CERAMIC FEM HD 36/0MM; PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/CERAMIC/POLYMER

Model Number N/A

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

Patient Problems Pain (1994); Swelling/ Edema (4577)

Event Date 04/26/2023

Event Type  Injury  

Event Description

It was reported that the patient underwent initial right hip total arthroplasty performed approximately 15 months ago.Subsequently, three months later, the patient received a cortisone injection for lateral hip pain and trochanteric bursitis.After a year from the initial surgery the patient reported mild pain, moderate difficulties with activities of daily living, snapping sensation, and difficulty sleeping and was prescribed corticosteroid injection into right trochanteric bursa, a topical pain relief gel, and prescription for physical therapy, possibly dry needling.Attempts have been made and no further information has been provided.

Manufacturer Narrative

(b)(4).D-10: ref.(b)(6) lot r7301744a g7 3 hole, g7 pps ltd acet shell 54f.Ref.(b)(6) lot 65459622 bone scr 6.5x35 self-tap.Ref.(b)(6) lot 65502075 g7 longevity neutral 36mm f.Ref.(b)(6) lot 213200 echo por fmrl lat nc 13x145mm.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

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

Manufacturer Narrative

This follow-up report is being submitted to relay additional information.Bursitis is the inflammation or irritation of the bursae (the fluid filled sac that cushions the joint) and is typically caused by repetitive motion, overuse, and pressure to the bursae.Bursitis is a very common condition that can impact any of the joints and can last for a short duration or years.Symptoms the patient can experience include pain, tenderness, swelling, stiffness, decrease in movement, and/or redness at or around the joint that is involved.Conservative treatment consists of over the counter (otc) medications pain relievers and anti-inflammatories, rest, ice, elevation, and applying pressure wraps.If conservative treatments fail, physical therapy, aspiration, arthroscopy, or steroid injections may be necessary.The complaint indicates that postop bursitis developed and required medical intervention for treatment.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.

• Brand Name: BIOLOX DELTA MODULAR CERAMIC FEM HD 36/0MM
• Type of Device: PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/CERAMIC/POLYMER
• 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: 19141719
• MDR Text Key: 340561459
• Report Number: 3002806535-2024-00151
• Device Sequence Number: 1
• Product Code: LZO
• UDI-Device Identifier: 00887868271175
• UDI-Public: (01)00887868271175(17)320912(10)3128005
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K192683
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Study,Company Representative
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date: 04/26/2024

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 Model Number: N/A
• Device Catalogue Number: 650-0661
• Device Lot Number: 3128005
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 04/19/2024
• Supplement Dates Manufacturer Received: 04/25/2024
• Supplement Dates FDA Received: 04/26/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/12/2022
• 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
• Treatment: SEE H11 NARRATIVE.
• Patient Outcome(s): Required Intervention
• Patient Sex: Female
• Patient Weight: 90 KG
• Patient Race: White