MAUDE Adverse Event Report: ZIMMER BIOMET, INC. FEMORAL STEM BEADED FULLCOAT 12/14; PROSTHESIS, HIP

Model Number	N/A
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Codes	Failure of Implant (1924); Pain (1994); Ambulation or Postural Difficulties (2544); Metal Related Pathology (4530)
Date of Event	10/22/2021
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that the patient was revised due to implant fracture approximately 16 years post implantation.The stem, head, shell, and liner were exchanged and competitor product was implanted.Attempts have been made and additional information on the reported event is unavailable at this time.
Additional Manufacturer Narrative
(b)(4).Catalog number: 00784301226 lot number: 60189250 brand name: versys beaded fullcoat stem.Catalog number: unknown lot number: 6022914 brand name: unknown.Unknown tm shell.Unknown longevity liner.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
No further event information available at the time of this report.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay additional information.Proposed component code: mechanical (g04)-stem.Review of the available records identified the following: patient was revised due to implant fracture.Revision notes were not provided, however pathology notes confirmed the stem fractured.All products were explanted, and zimmer products were placed in conjunction with competitor product.Reported event was confirmed by review of medical records provided.Review of the device history record identified no deviations or anomalies during manufacturing related to the reported event.Root cause could not be determined as the necessary information to adequately investigate the reported event was not provided.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
It was reported right initial hip arthroplasty.Subsequently, the patient underwent a revision approximately 16 years post implantation due to implant fracture.During the revision metallosis was noted and cleaned throughout the joint cavity.The acetabular shell was found to be well positioned and well fixed.The stem, head, and liner were exchanged.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay additional information.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay additional information.The following sections were {update/corrected}.Updated: g3; h2.Additional medical records were provided and reviewed by a health care professional.Review of the available records identified the following: it was reported there was an initial tha.A revision occurred on due to pain and the inability to ambulate.The stem was found to be broken with metallosis in the joint.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 information at the time of this report.
Event or Problem Description
No further information at the time of this report.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay additional information.The following sections were {update/corrected}.Corrected: d4.Updated: d9; g3; h2; h6.Visual examination of the returned product identified stem was confirmed fractured with both pieces returned.Femoral head was returned mated to the stem.Beaded coating on the proximal end has bio debris and scratches.Distal end piece has bone or bone cement attached with bio debris embedded in the beaded coating.Scratches are noted to the distal tip.No other damage was noted.The stem was submitted for further analysis.Analysis determined step-like artifacts were observed on the fracture surface consistent with fatigue fracture.Root cause unchanged.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.

• Brand Name: FEMORAL STEM BEADED FULLCOAT 12/14
• Common Device Name: PROSTHESIS, HIP
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 1800 w. center st.; warsaw IN 46580
• Manufacturer (Section G): ZIMMER BIOMET, INC.; 1800 w. center st.; warsaw IN 46580
• Manufacturer Contact: jennifer rapsavage ; 56 e. bell dr.; warsaw, IN 46582 ; 5745260384
• MDR Report Key: 14759221
• Report Number: 0001822565-2022-01840
• Device Sequence Number: 13776604
• Product Code: LPH
• UDI-Device Identifier: 00889024136502
• UDI-Public: (01)00889024136502(17)141031(10)60189250
• Combination Product (Y/N): N
• Initial Reporter State: NY
• Initial Reporter Country: US
• PMA/510(K) Number: K973714
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2005
• Device Explanted Year: 2021
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Consumer,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup,Followup,Followup
• Report Date (Section B): 09/19/2025

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
• Operator of Device: Health Professional
• Device Expiration Date: 10/31/2014
• Device Model Number: N/A
• Device Catalogue Number: 00784301226
• Device Lot Number: 60189250
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• 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: 06/03/2022
• Supplement Date Received by Manufacturer: 07/19/2022; 05/16/2024; 10/01/2024; 09/15/2025
• Initial Report FDA Received Date: 06/21/2022
• Supplement Report FDA Received Date: 07/29/2022; 05/30/2024; 10/03/2024; 09/19/2025
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 10/20/2004
• 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 H10 NARRATIVE.
• Outcome Attributed to Adverse Event: Required Intervention; Hospitalization
• Patient Sex: Male
• Patient Weight: 100 KG