MAUDE Adverse Event Report: ZIMMER GMBH BIOLOX® DELTA, CERAMIC FEMORAL HEAD, S, ø 32/-3.5, TAPER 12/14; HIP PROSTHESIS

Catalog Number	00877503201
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Pain (1994); Bursitis (4832)
Date of Event	12/16/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).D10: g7 osseoti multihole 50mm d, #item: 110010263, #lot: 65175033.Bone screw self-tapping 6.5 mm dia, #item: 00625006525, #lot: j7051238.Bone screw self-tapping 6.5 mm dia, #item: 00625006530, #lot: j7130460.32mm i.D.Size d high wall liner, #item: 30123204, #lot: 64611110.Femoral stem press-fit collarless 12/14 neck taper standard, #item: 00786401320, #lot: 64924752.Therapy date: on (b)(6) 2024.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 a patient had an initial right total hip replacement and subsequently, approximately three years post-op reported moderate pain and was diagnosed with right trochanteric bursitis and given a cortisone injection.All implants remain in place.Attempts have been made and all available information has been provided.
Event or Problem Description
It was reported a patient had an initial right total hip replacement and subsequently, approximately two years post-op reported moderate pain and was diagnosed with right trochanteric bursitis and given a cortisone injection.A second injection was required at the three-year follow up due to recurrent right trochanteric bursitis.Follow up notes indicate that the patient is noncompliant with posterior hip precautions as observed by the patient crossing her legs several times while sitting in the office.All implants remain in place.Attempts have been made and all available information has been provided.
Additional Manufacturer Narrative
Follow up report (b)(4).Updated: b4,b5,b6,b7,d2,e1,e2,e3,g1,g3,g6,h1.H2 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.
Event or Problem Description
No additional event information.
Additional Manufacturer Narrative
Follow up report: (b)(4).Updated: b4, b5, d2, d9, g1, g3, g6, h1, h2, h6.Product has not been returned.No product evaluation was able to be completed.Devices are used for treatment.Reported event is not related to device therefore, a compatibility review is not applicable.No further actions will be initiated as a result of reported event.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.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.
Event or Problem Description
No additional event information.
Additional Manufacturer Narrative
Follow up report (b)(4).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, CERAMIC FEMORAL HEAD, S, ø 32/-3.5, TAPER 12/14
• 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: 21740255
• Report Number: 0009613350-2025-00210
• Device Sequence Number: 12961198
• Product Code: LZO
• UDI-Device Identifier: 00889024430310
• UDI-Public: (01)00889024430310(17)310617(10)3073979
• Combination Product (Y/N): N
• Initial Reporter State: IN
• Initial Reporter Country: US
• PMA/510(K) Number: K192416
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted 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,Followup
• Report Date (Section B): 08/12/2025

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: 00877503201
• Device Lot Number: 3073979
• 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: 03/12/2025
• Supplement Date Received by Manufacturer: 04/07/2025; 07/08/2025; 07/23/2025
• Initial Report FDA Received Date: 04/01/2025
• Supplement Report FDA Received Date: 04/28/2025; 07/16/2025; 08/12/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/17/2021
• 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 Age: 48 YR
• Patient Sex: Female
• Patient Weight: 83 KG