MAUDE Adverse Event Report: ZIMMER GMBH BIOLOX DELTA HEAD 12/14 32X0; PROSTHESIS, HIP

Catalog Number	00-8775-032-02
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Pain (1994); Bursitis (4832)
Date of Event	07/11/2023
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).D10.Femoral stem press-fit collarless 12/14 neck taper standard body extended neck offset size 11 117 mm stem length cementless item#: 00786401120, lot#: 64960534.G7 longevity high wall 32mm d item#: 20123204, lot#: 64580197.Bone screw self-tapping 6.5 mm dia.35 mm length item#: 00625006535, lot#: j7259867.Bone screw self-tapping 6.5 mm dia.25 mm length item#: 00625006525, lot#: j7278087.G7 osseoti multihole 50mm d item#: 110010263, lot#: 65210707.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 will be submitted.
Event or Problem Description
It was reported from a clinical study that a patient underwent a right total hip arthroplasty.Subsequently, the patient experienced ongoing trochanteric bursitis requiring cortisone injections at 11, 16, and 19 months postop.No complications concerning the implants have been identified on x-ray.Due diligence is in process and no further information on the reported event has been provided.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay additional information.The following sections were updated: b4, g3, g6, h2, h3, h6, h11.Corrected: h6 (component code).Review of the reported event by a health care professional found: 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.No product was returned or pictures provided; visual and dimensional evaluations could not be performed.The root cause of the reported event was determined to be unrelated to the device.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
Diligence is completed and no further information on the reported event has been provided.

• Brand Name: BIOLOX DELTA HEAD 12/14 32X0
• Common Device Name: PROSTHESIS, HIP
• 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: 22897818
• Report Number: 0009613350-2025-00676
• Device Sequence Number: 8957814
• Product Code: LZO
• UDI-Device Identifier: 00889024430327
• UDI-Public: (01)00889024430327(17)320224(10)3103842
• 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: Study,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 03/06/2026

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: 00-8775-032-02
• Device Lot Number: 3103842
• 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: 08/01/2025
• Supplement Date Received by Manufacturer: 03/03/2026
• Initial Report FDA Received Date: 08/26/2025
• Supplement Report FDA Received Date: 03/06/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/24/2022
• 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: Other
• Patient Age: 69 YR
• Patient Sex: Female
• Patient Weight: 91 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White