MAUDE Adverse Event Report: ZIMMER GMBH BIOLOX® OPTION, HEAD, M, ø 36/0, TAPER 12/14; PROSTHESIS, HIP

Catalog Number	00877703602
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Inflammation (1932); Pain (1994); Ambulation or Postural Difficulties (2544); Joint Laxity (4526); Metal Related Pathology (4530); Bursitis (4832); Joint Impingement (4834); Joint effusion (4849)
Date of Event	04/11/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).D10: item#: 00875101036, 36mm i.D.Size ii neutral liner use with 52mm o.D.Size ii shell, lot#: 64914989.Item#: 00875705202, 52mm o.D.Size ii porous uncemented with multi-holes shell use with ii liners, lot#: 61629434.Item#: 00771100900, femoral stem 12/14 neck taper plasma sprayed press-fit cementless size 9 standard offset, lot#: 61559510.Item#: 00625006520, bone screw self-tapping 6.5 mm dia.20 mm length, lot#: 61738443.Item#: 00625006535, bone screw self-tapping 6.5 mm dia.35 mm length, lot#: 61738504.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 that the patient underwent a right tha.Subsequently, it was reported the patient had a right tha revision due to metal related pathology with liner and head revised.Subsequently, after approximately one year and four months patient reports post revision right hip pain, limp, giving out of hip.Tests revealed trochanteric bursal reactive tissue, surgeon discussed plan to excise the area and assess for any further tissue damage at that time.No documentation procedure or revision has occurred.Attempts have been made and additional information on the reported event is unavailable at this time.
Additional Manufacturer Narrative
(b)(4).This follow-up report is being submitted to relay additional information.The following sections were updated: b4, g3, g6, h2, h3, h6, h11.No product was returned or pictures provided; visual and dimensional evaluations could not be performed.A review of the device manufacturing records confirmed no abnormalities or deviations.Review of the complaint history found no additional related complaints for this item and the reported part and lot combination.Medical records were provided and reviewed by a health care professional.Review of the available records identified the following: pain with hip flexion & external rotation, fluid collection near gtbursa & bone.Mild chronic inflammation, calcification and ischemic necrosis - limp, ambulation issues, pain.Biopsy results typical of metal related reaction.Impression - bursitis, possible abductor tear.This event is post revision pain consistent with trochanteric bursal reactive tissue.Based on the available information, the reported event can be confirmed.A definitive root cause cannot be determined.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 further event information available at the time of this report.

• Brand Name: BIOLOX® OPTION, HEAD, M, ø 36/0, TAPER 12/14
• 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: 21740079
• Report Number: 0009613350-2025-00209
• Device Sequence Number: 4109077
• Product Code: LZO
• UDI-Device Identifier: 00889024430525
• UDI-Public: (01)00889024430525(17)320624(10)3120597
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: K192416
• 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: Consumer,Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 07/03/2025

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: 00877703602
• Device Lot Number: 3120597
• 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: 03/06/2025
• Supplement Date Received by Manufacturer: 06/24/2025
• Initial Report FDA Received Date: 04/01/2025
• Supplement Report FDA Received Date: 07/03/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/24/2022
• 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
• Outcome Attributed to Adverse Event: Other
• Patient Age: 51 YR
• Patient Sex: Female
• Patient Weight: 86 KG