MAUDE Adverse Event Report: ZIMMER MANUFACTURING B.V. FEMORAL HEAD STERILE PRODUCT DO NOT RESTERILIZE 12/14 TAPER; PROSTHESIS, HIP

Model Number N/A

Device Problems Corroded (1131); Insufficient Information (3190)

Patient Problems Pain (1994); Metal Related Pathology (4530); Unequal Limb Length (4534)

Event Date 06/11/2019

Event Type  Injury  

Manufacturer Narrative

(b)(4).Concomitant medical products: 00-8757-060-01 lot 62681027 continuum shell 60mm.00-8751-014-36 lot 62527466 continuum liner 36mm.00-7711-011-00 lot 62350683 m/l taper stem.Reported event was confirmed by review of medical records received.Revision op notes demonstrated that the patient was revised due to pain, limb length discrepancy, and subsidence of the well-fixed femoral stem.During the revision, black debris was noted in the femoral head.The head, liner, and stem were replaced without complication.The device history record (dhr) was reviewed and no discrepancies relevant to the reported event were found.Root cause was unable to 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.Multiple mdr reports were filed for this event, please see associated reports: 0001822565-2020-00725.

Event Description

It was reported patient underwent initial right total hip arthroplasty.Subsequently, the patient was revised on approximately 5 years post implantation due to pain, limb length discrepancy, and subsidence of the femoral stem.During the revision, black debris was noted in the femoral head.The head, liner, and stem were replaced without complication.

Event Description

No further event information is available at the time of this report.

Manufacturer Narrative

This follow-up report is being submitted to relay additional information.H6: component code: mechanical (g04) - head.Product was returned and evaluated.A visual examination of the returned product identified some scuffing to the taper of the head, along with a wear line on the outside diameter of the device.The stem had debris on the porous area along with gouging to the body and to the taper.The reported issue was confirmed based on the provided medical records and returned devices.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.

• Brand Name: FEMORAL HEAD STERILE PRODUCT DO NOT RESTERILIZE 12/14 TAPER
• Type of Device: 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: christina arnt ; 56 e. bell dr.; warsaw, IN 46582 ; 5745273773
• MDR Report Key: 10101527
• MDR Text Key: 193030361
• Report Number: 0002648920-2020-00283
• Device Sequence Number: 1
• Product Code: LPH
• Combination Product (y/n): N
• Reporter Country Code: GG
• PMA/PMN Number: K032726
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 01/05/2024

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 Operator: Health Professional
• Device Expiration Date: 04/30/2024
• Device Model Number: N/A
• Device Catalogue Number: 00801803602
• Device Lot Number: 62682865
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 05/21/2020
• Initial Date FDA Received: 05/29/2020
• Supplement Dates Manufacturer Received: 12/29/2023
• Supplement Dates FDA Received: 01/05/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/16/2014
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Removal/Correction Number: N/A
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Sex: Male
• Patient Weight: 106 KG