MAUDE Adverse Event Report: ZIMMER MANUFACTURING B.V. FEMORAL HEAD 28 MM DIAMETER MEDIUM 7 MM NECK LENGTH; PROSTHESIS, HIP

Catalog Number 00902602900

Device Problem Material Erosion (1214)

Event Type  Injury  

Event Description

It was reported a patient has been indicated for a right hip revision approximately 19 years post implantation due to loosening and elevated metal ion levels.The shell that is to be revised is a competitor product.To date, no revision has taken place.Attempts have been made and no further information is available.

Manufacturer Narrative

(b)(4).Multiple mdr reports were filed for this event, please see associated reports: 0001822565-2023-02269.D10: cat #: 6302-1-058 / howmedica acetabular vitalcok cluster shell 58mm / lot #: crtzd9420292; cat #: 00663001600 / multilock femoral stem 16 mm / lot #: 73950600.G2: canada.Proposed component code: mechanical (g04)- head.No product was returned or pictures provided; visual and dimensional evaluations could not be performed.Medical records were provided and reviewed by a health care professional for the initial surgery and previous revision.The initial and 1st revision surgery noted no complications and confirmed the off label use.Medical records were not provided in relation to the upcoming revision.The complaint could not be confirmed.The provided medical records were not in relation to this potential revision.Dhr was reviewed and no discrepancies related to the reported event were found.A definitive root cause was unable to 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 28 MM DIAMETER MEDIUM 7 MM NECK LENGTH
• 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: jennifer rapsavage ; 56 e. bell dr.; warsaw, IN 46582 ; 5745260384
• MDR Report Key: 18039080
• MDR Text Key: 326968135
• Report Number: 0002648920-2023-00260
• Device Sequence Number: 1
• Product Code: JDI
• Combination Product (y/n): N
• Reporter Country Code: CA
• PMA/PMN Number: K960278
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Distributor
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 10/31/2023

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: 06/30/2013
• Device Catalogue Number: 00902602900
• Device Lot Number: 60060928
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 10/19/2023
• Initial Date FDA Received: 10/31/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 06/25/2003
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Treatment: SEE H10 NARRATIVE
• Patient Outcome(s): Other
• Patient Age: 75 YR
• Patient Sex: Male