MAUDE Adverse Event Report: ZIMMER GMBH BIOLOX DELTA HD 12/14 36X+3.5; HIP PROSTHESIS

Catalog Number	00-8775-036-03
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Pain (1994); Bursitis (4832)
Date of Event	08/16/2023
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).D10: g7 osseoti multihole, #item 110010266, #lot 65300751, bone screw self-tapping, #item 00625006525, #lot j7217788, bone screw self-tapping, #item 00625006540, #lot j7240913, g7 longevity high, #item 20123606, #lot 65454289, femoral stem press-fit, #item 00786401420, #lot 63159639 therapy date: (b)(6) 2023.Attempts have been made to gather all product identification information and no further information has been provided.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 a patient had an initial right total hip arthroplasty performed.At the 1 year follow up visit, the patient reported tenderness over the greater trochanter consistent with bursitis for which the surgeon provided a cortisone injection.At subsequent follow ups, the patient reported no further pain, difficulties, or complications.Attempts have been made and additional information on the reported event is unavailable at this time.
Event or Problem Description
No additional event information.
Additional Manufacturer Narrative
Follow up report (b)(4).Updated: b4, b5, d2, g1, g3, g6, h1, h2, h6 corrected: d4, h4, h6 (component codes) product has not been returned.No product evaluation was able to be completed.Reported event is not related to device therefore, a compatibility review is not applicable.Root cause of the reported event is not device related.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.Radiographs indicate no concerns with positioning or alignment of implants, and the issue resolved without surgical intervention.If any further information is found which would change or alter any conclusions or information, a supplemental will be filed accordingly.Zimmer biomet will continue to monitor for trends.

• Brand Name: BIOLOX DELTA HD 12/14 36X+3.5
• Common Device Name: HIP PROSTHESIS
• Manufacturer (Section D): ZIMMER GMBH; sulzer allee 8; sulzer industrie park; winterthur
• Manufacturer (Section G): ZIMMER GMBH; sulzer allee 8; sulzer industrie park; winterthur 8404 ; SZ 8404
• Manufacturer Contact: jennifer rapsavage ; 56 e. bell dr.; warsaw, IN 46582 ; 5745260384
• MDR Report Key: 22850507
• Report Number: 0009613350-2025-00658
• Device Sequence Number: 8421901
• Product Code: LZO
• UDI-Device Identifier: 00889024430372
• UDI-Public: (01)00889024430372(17)320119(10)3099852
• Combination Product (Y/N): N
• Initial Reporter State: IN
• Initial Reporter Country: US
• PMA/510(K) Number: K200112
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2022
• 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
• Report Date (Section B): 10/06/2025

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: 00-8775-036-03
• Device Lot Number: 3099852
• 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: 07/31/2025
• Supplement Date Received by Manufacturer: 09/16/2025
• Initial Report FDA Received Date: 08/20/2025
• Supplement Report FDA Received Date: 10/06/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 01/19/2022
• 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
• Concomitant Medical Products and Therapy/Usage Dates: SEE H11 NARRATIVE.
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention
• Patient Sex: Female
• Patient Weight: 111 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White