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

Catalog Number 00663001600

Device Problem Patient Device Interaction Problem (4001)

Patient Problems Ossification (1428); Osteolysis (2377)

Event Date 06/15/2004

Event Type  Injury  

Manufacturer Narrative

(b)(4).Multiple mdr reports were filed for this event, please see associated reports: 0001822565-2023-02431.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 underwent a hip revision approximately eight years post implantation due to wear and osteolysis.During the revision heterotopic ossification was noted at the greater trochanter.The head and liner were replaced without complications.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; 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.Review of the available records identified the following: an initial right tha was performed with no complications noted.A mix of competitor and zb products were placed.A revision occurred approximately eight years later due to wear and osteolysis.During the revision, heterotopic ossification was noted at the greater trochanter.The zb head and liner were explanted and replaced with a mix of zb and competitor products.The complaint is confirmed based on the provided medical records.Dhr was not reviewed for the stem as the reported event was determined to be unrelated to the device.No problem was found, after a review by a health care professional it was determined that the heterotrophic ossification is unrelated to the stem.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 16MM
• 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: 17701815
• MDR Text Key: 322877630
• Report Number: 0001822565-2023-02430
• 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,Distributor
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 10/26/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/07/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• 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
• Date Manufacturer Received: 10/23/2023
• 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: UNKNOWN LINER.
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 75 YR
• Patient Sex: Male