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

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); Loss of Range of Motion (2032); Unequal Limb Length (4534)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).D10: xlpe 10 deg poly liner, #item 00631005632, #lot 62945897.Tm prim fem st, #item 00786401300, #lot 63172379.Tm acet shell, #item 00620205620, #lot 62658917.Bone scr 6.5x25, #item 00625006525, #lot 53165860.Trilogy bone scr, #item 00625006530, #lot 63160168.Therapy date: unknown.Attempts have been made to gather all product identification information and no further information has been provided.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 left hip implantation and subsequently experienced leg length discrepancy, pain, and limitations in range of motion.The patient stated these symptoms had persisted for approximately nine years post-implantation.The patient sought confirmation that the implant was adequate for their build and indicated their physician had dismissed the concerns.No details were provided regarding device malfunction, intraoperative issues, or device inspection.No revision or other surgical intervention was reported.No environmental factors were reported.Attempts have been made and no further information has been provided.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay additional information.The following sections were updated: b4,b5,d2,g1,g3,g6,h1,h2,h3,h6 the cmp was confirmed 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.The reported products were reviewed for compatibility with no issues noted.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.Complaints are monitored per complaint trending process in order to identify potential adverse trends.Medical records and radiographs were provided and reviewed by a health care professional and a radiologist.The review of the initial surgery report identified a posterolateral approach of a tha performed with no complications, excellent fit and stability with full rom testing.Patient was discharged stable pod 2 with home pt, posterior hip precautions.Review of the the radiologist's case report identified that the teardrop-top to lesser trochanter distance is greater on the left compared with the right, which could result in a leg length discrepancy (left longer than right).In addition, the left hip acetabular cup shows lateral overhang.Possible acetabular cup malpositioning or sizing concern was identified as a contributing factor to the event.A definitive root cause could not 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 information is available at the time of this report.

• Brand Name: BIOLOX DELTA HEAD 12/14 32X0
• 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
• Manufacturer Contact: jennifer rapsavage ; 56 e. bell dr.; warsaw, IN 46582 ; 5745260384
• MDR Report Key: 23496034
• Report Number: 0009613350-2025-00864
• Device Sequence Number: 21091891
• Product Code: LZO
• UDI-Device Identifier: 00889024430327
• UDI-Public: (01)00889024430327(17)250331(10)2794384
• Combination Product (Y/N): N
• Initial Reporter State: NJ
• Initial Reporter Country: US
• PMA/510(K) Number: K200112
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2015
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Consumer,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 04/07/2026

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 Expiration Date: 03/31/2025
• Device Catalogue Number: 00-8775-032-02
• Device Lot Number: 2794384
• 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: 10/21/2025
• Supplement Date Received by Manufacturer: 04/01/2026
• Initial Report FDA Received Date: 11/07/2025
• Supplement Report FDA Received Date: 04/07/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/01/2015
• 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; Other
• Patient Age: 54 YR
• Patient Sex: Male
• Patient Weight: 86 KG