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

Catalog Number	00877503601
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Tendinopathy (4887)
Date of Event	06/27/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).D10.G7 pps ltd acet shell 50d item# 010000662, lot# r7304614a.G7 vit e neutral lnr 36mm d item# 30103604, lot# 65627113.Avenir cmpl ha std col size 4 item# 574201040, lot# 3060082.Bone screw self-tapping 6.5 mm dia.25 mm length, item# 00625006525, lot# j7375821.Bone screw self-tapping 6.5 mm dia.25 mm length, item# 00625006525, lot# j7375825.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 an initial left total hip arthroplasty.Subsequently, the patient reported mild left hip flexor tendinitis at 18 months follow up.After prescribed physical therapy, the complication was marked as resolved approximately 2 years and 3 months post implantation.Diligence is completed 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: a5, h4.Product has not been returned.No product evaluation was able to be completed.Devices are used for treatment.Root cause of the reported event is not device related.Tendonitis is the inflammation or irritation of the tendons and is typically caused by repetitive motion, overuse and pressure to the bursae.Symptoms the patient can experience, pain, tenderness, swelling, stiffness, decrease in movement, and/or redness at or around the joint that is involved.This can impact the patients¿ ability to use the joint to their full potential.Patient can experience a decrease with overall adls, rom of the joint, decrease in quality of life, as well as increasing the need for possible over the counter (otc) medications for swelling and pain control.Treatment for tendonitis can consist of, otc medications, such as tylenol and anti-inflammatories, prescribed pain medications, physical therapy, rest, ice, elevating the affected joint and steroid injections.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 HD 12/14 36X-3.5
• 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: 22029348
• Report Number: 0009613350-2025-00375
• Device Sequence Number: 8351035
• Product Code: LZO
• UDI-Device Identifier: 00889024430358
• UDI-Public: (01)00889024430358(17)320608(10)3115418
• Combination Product (Y/N): N
• Initial Reporter State: OR
• 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: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 07/23/2025

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: 00877503601
• Device Lot Number: 3115418
• 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: 04/23/2025
• Supplement Date Received by Manufacturer: 07/08/2025
• Initial Report FDA Received Date: 05/15/2025
• Supplement Report FDA Received Date: 07/23/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/08/2022
• 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: 68 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White