MAUDE Adverse Event Report: ZIMMER MANUFACTURING B.V. FEMORAL HEAD +0X28MM DIA; PROSTHESIS, HIP

Catalog Number	00801802802
Medical Device Problem Code	Device Dislodged or Dislocated (2923)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/02/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4) d10: unknown ¿ unknown liner ¿ unknown , item 00784800300 - modular neck s 12/14 neck taper use with +0 heads only - lot 62782925, unknown ¿ unknown shell¿ unknown, unknown ¿ unknown stem¿ unknown.H6: proposed component code: mechanical (g04) - head.The reported device had been returned for analysis.Once the investigation is completed, a supplemental mdr will be submitted.
Event or Problem Description
It was reported that the patient underwent a left hip revision approximately 10 years post implantation due to dislocation.During the procedure, the cup was found to be malpositioned, and the trunnion of the neck was impinging on the posterior elevated rim of the acetabular liner.The cup was explanted, and new cup was implanted in a better position.The neck was changed and adjusted to accommodate the new cup position.No additional information available for the reported event.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay additional information.The following sections were updated: d4; g3; h2; h3; h4; h6; h10.Visual examination of the returned product identified wear marks on the internal taper of the femoral head.Light scratches are also present on the o.D.Of the head.Wear marks were identified on the trunnion taper and distal tapered end.There are indentation marks at the base of the trunnion taper as well as nicks on the taper.No other damage was noted during visual evaluation.Where measured, the devices were conforming.Review of the device history records identified no deviations or anomalies during manufacturing for the head and neck.A definitive root cause cannot be determined.It is unknown if the cup moved to become malpositioned or was placed that way originally.The placement of implants is at the surgeon's discretion regarding patient anatomy.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 trends.
Event or Problem Description
No additional information available for the reported event.

• Brand Name: FEMORAL HEAD +0X28MM DIA
• Common Device Name: PROSTHESIS, HIP
• Manufacturer (Section D): ZIMMER MANUFACTURING B.V.; turpeaux industrial park; route #1 km 123.4 bldg #1; mercedita PR 00715
• Manufacturer (Section G): ZIMMER MANUFACTURING B.V.; turpeaux industrial park; route #1 km 123.4 bldg #1; mercedita PR 00715
• Manufacturer Contact: jennifer rapsavage ; 56 e. bell dr.; warsaw, IN 46582 ; 5745260384
• MDR Report Key: 22336775
• Report Number: 0002648920-2025-00175
• Device Sequence Number: 8993952
• Product Code: LPH
• UDI-Device Identifier: 00889024144620
• UDI-Public: (01)00889024144620(17)240930(10)62839797
• Combination Product (Y/N): N
• Initial Reporter State: NC
• Initial Reporter Country: US
• PMA/510(K) Number: K953337
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2015
• Device Explanted Year: 2025
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,Distributor
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 11/05/2025

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?: Yes
• Device Expiration Date: 09/30/2024
• Device Catalogue Number: 00801802802
• Device Lot Number: 62839797
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/11/2025
• 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: 06/02/2025
• Supplement Date Received by Manufacturer: 11/05/2025
• Initial Report FDA Received Date: 06/26/2025
• Supplement Report FDA Received Date: 11/14/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/29/2014
• 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
• If action reported to FDA under 21 USC 360i(g), list FDA-assigned Recall Number or include a statement: N/A
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: SEE H11
• Outcome Attributed to Adverse Event: Required Intervention; Hospitalization
• Patient Age: 85 YR
• Patient Sex: Female