MAUDE Adverse Event Report: ZIMMER BIOMET, INC. MULTILOCK FEMORAL STEM 16 MM; PROSTHESIS, HIP

Catalog Number 00663001600

Device Problem Material Erosion (1214)

Event Type  Injury  

Manufacturer Narrative

(b)(4).Multiple mdr reports were filed for this event, please see associated reports: 0001822565-2023-02268.D10: cat #: 6302-1-058 / howmedica acetabular vitalcok cluster shell 58mm / lot #: crtzd9420292.Cat #: 00902602600 / fem hd 26mmdia med nk / lot #: 8441000.G2: canada.The device will not be returned for analysis; however, an investigation of the reported event is in progress.Once the investigation is completed, a supplemental medwatch will be submitted.

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.

Event Description

No additional event information to report at this time.

Manufacturer Narrative

(b)(4).This follow-up report is being submitted to relay additional information.The following sections were updated/corrected updated: b4; b5; d4; g3; h2; h3; h4; h6 proposed component code: mechanical (g04)- stem 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 recordsrecords 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: MULTILOCK FEMORAL STEM 16 MM
• Type of Device: 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: 17632287
• MDR Text Key: 322065865
• Report Number: 0001822565-2023-02269
• Device Sequence Number: 1
• Product Code: JDI
• Combination Product (y/n): N
• Reporter Country Code: CA
• PMA/PMN Number: K902436
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 10/30/2023

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: 04/30/2001
• Device Catalogue Number: 00663001600
• Device Lot Number: 73950600
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 08/01/2023
• Initial Date FDA Received: 08/28/2023
• Supplement Dates Manufacturer Received: 10/19/2023
• Supplement Dates FDA Received: 10/31/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 04/12/1991
• 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