MAUDE Adverse Event Report: ZIMMER MANUFACTURING B.V. FEMORAL STEM 12/14 NECK TAPER EXT. OFFSET SIZE 0 105 MM STEM LENGTH; PROSTHESIS, HIPS

Model Number	N/A
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
Additional Manufacturer Narrative
(b)(4).G2: foreign: united kingdom.Proposed component code: mechanical (g04): stem.Customer has indicated that the product will not be returned to zimmer biomet for investigation.The investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.
Event or Problem Description
It was reported that the patient underwent a bilateral hip arthroplasty and was implanted with zimmer biomet products.The patient was revised in the right hip due to the stem implant fracturing.The patients report to be suffering from pain due to the implant in the left hip.Attempts have been made and no additional information is available.
Event or Problem Description
It was reported by legal that a patient had an initial left total hip arthroplasty performed.Subsequently, the patient has reported ongoing pain and decreased quality of life since the implantation.Patients relay fear of not being able to walk unaided in the future.No further information has been provided.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay additional and/or corrected information.Updated: a2, a3, a4, b1, b2, b3, b5, b7, d1, d4, d6a, d10, g3, g6, h2, h4, h6.D10: 00875200832 32mm i.D.Size gg elevated rim liner use with 48mm o.D.Size gg shell 66043601.00875704801 48mm o.D.Size gg porous uncemented with cluster holes shell use with gg liners 66057871.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay additional and/or corrected information.Updated: d4, g3, g6, h2, h3, h4, h6, h10.No product was returned or pictures provided; visual and dimensional evaluations could not be performed.Review of the device history records identified no deviations or anomalies during manufacturing related to the reported event.Medical records were not provided in relation to this reported event.A definitive root cause cannot be determined.This complaint cannot be confirmed.If any further information is found which would change or alter any conclusions or information, a supplemental report will be filed accordingly.Zimmer biomet will continue to monitor trends.
Event or Problem Description
No additional event information to report at this time.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay additional information.The following sections were updated: b4, b5, g3, g6, h2, h3, h6, h11.The reported event could not be confirmed due to lack of product/information.No product was returned or pictures provided; visual and dimensional evaluations could not be performed.Review of the device history records identified no deviations or anomalies during manufacturing related to the reported event.Medical records provided only confirm that a left total hip replacement is in situ.Additional records relating to the left side were not provided.A definitive root cause cannot be determined.If any further information is found which would change or alter any conclusions or information, a supplemental report will be filed accordingly.Zimmer biomet will continue to monitor for trends.
Event or Problem Description
No additional event information.

• Brand Name: FEMORAL STEM 12/14 NECK TAPER EXT. OFFSET SIZE 0 105 MM STEM LENGTH
• Common Device Name: PROSTHESIS, HIPS
• 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: 21865474
• Report Number: 0002648920-2025-00116
• Device Sequence Number: 4695571
• Product Code: JDI
• UDI-Device Identifier: 00889024145740
• UDI-Public: (01)00889024145740(17)330520(10)65885695
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• PMA/510(K) Number: K191735
• 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,Followup
• Report Date (Section B): 04/14/2026

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?: Yes
• Operator of Device: Lay User/Patient
• Device Model Number: N/A
• Device Catalogue Number: 00811400010
• Device Lot Number: 65885695
• 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: 03/27/2025
• Supplement Date Received by Manufacturer: 04/23/2025; 07/16/2025; 04/08/2026
• Initial Report FDA Received Date: 04/18/2025
• Supplement Report FDA Received Date: 05/14/2025; 08/05/2025; 04/14/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/23/2023
• 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: Hospitalization; Required Intervention; Other
• Patient Age: 49 YR
• Patient Sex: Female
• Patient Weight: 104 KG