MAUDE Adverse Event Report: ZIMMER GMBH BIOLOX DELTA HD 12/14 32X+3.5; PROSTHESIS, HIP

Catalog Number	00877503203
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Pain (1994); Ambulation or Postural Difficulties (2544)
Date of Event	12/09/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported by legal that a patient had an initial left total hip arthroplasty performed.Subsequently, approximately 6 months post-implantation the patient has reported ongoing pain and decreased quality of life since implantation.Patient relays fear of not being able to walk unaided in the future.No further information has been provided.Attempts have been made and additional information on the reported event is unavailable at this time.
Additional Manufacturer Narrative
(b)(4): d10: item # 00811400010, femoral stem 12/14 neck taper ext.Offset size 0 105 mm stem length, lot # 65885695.Item # 00875200832, 32mm i.D.Size gg elevated rim liner use with 48mm o.D.Size gg shell, lot # 66043601.Item # 00875704801, 48mm o.D.Size gg porous uncemented with cluster holes shell use with gg liners, lot # 66057871.Item # 66017569, palacos cement, lot # 67331292.Item # unknown, cement restrictor, lot # unknown.G2: report source united kingdom.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.
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; a product evaluation could not be performed.A review of the device manufacturing records confirmed no abnormalities or deviations.Review of the complaint history identified additional similar complaints for the reported item and no additional similar complaints for the reported part and lot combination.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.
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, h11.Medical records were provided and reviewed by a health care professional.The review x-ray shows there is a left total hip replacement in situ.Satisfactory position of prosthesis.Ct scan shows bilateral total hip replacement in situ.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 DELTA HD 12/14 32X+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: 22045318
• Report Number: 0009613350-2025-00379
• Device Sequence Number: 8899320
• Product Code: LZO
• UDI-Device Identifier: 00889024430334
• UDI-Public: (01)00889024430334(17)330720(10)3166161
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• PMA/510(K) Number: K192416
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2023
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Consumer
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 02/27/2026

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: 00877503203
• Device Lot Number: 3166161
• Was Device Available for Evaluation?: No
• 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: 04/17/2025; 02/11/2026
• Initial Report FDA Received Date: 05/19/2025
• Supplement Report FDA Received Date: 10/29/2025; 02/27/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/23/2023
• 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: 49 YR
• Patient Sex: Female
• Patient Weight: 104 KG