MAUDE Adverse Event Report: ZIMMER BIOMET, INC. FEMORAL HEAD STERILE PRODUCT DO NOT RESTERILIZE 12/14 TAPER; PROSTEHSIS, HIP

Catalog Number 00801803202

Device Problems Naturally Worn (2988); Patient Device Interaction Problem (4001)

Patient Problems Failure of Implant (1924); Necrosis (1971); Pain (1994); Metal Related Pathology (4530)

Event Date 10/05/2022

Event Type  Injury  

Manufacturer Narrative

(b)(4).Multiple mdr reports were filed for this event, please see associated reports: 0001822565-2023-01767 0001822565-2023-01768 0001822565-2023-01770 0001822565-2023-01771 d10: unknown kinectiv stem unknown kinectiv neck unknown trilogy shell unknown longevity liner 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 that a patient underwent a left hip revision approximately 13 years post implantations due to pain, metal relation pathology, elevated metal ion levels and periprosthetic fluid.During the procedure, black debris and necrotic tissue were observed and the bursal tissue was dissected.A periprosthetic fracture also occurred during attempted removal of initial components which required repair with cerclage wires and a small plate.The head and stem were ultimately exchanged with competitor product and there were no further complications noted.Attempts have been made and no further information is available.

Manufacturer Narrative

(b)(4).This follow-up report is being submitted to relay additional information.Proposed component code: mechanical (g04)- head.No product was returned or pictures provided; visual and dimensional evaluations could not be performed.Device history record (dhr) review was unable to be performed as the lot number of the device involved in the event is unknown.The complaint was confirmed based on the provided medical records.Root cause was unable to 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 Description

No additional event information to report at this time.

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.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 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; d1; d4; g3; g4; h2; h3; h4; h6.Visual examination of the returned product identified there are scratches present and some damage to the taper edge of the taper and flat for the femoral head.The head, neck, and stem were submitted for further analysis.Analysis determined a consensus score of 4 for the head.The complaint is confirmed based on the provided medical records and returned devices.Dhr was reviewed and no discrepancies related to the reported event were found.Root cause remains 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 HEAD STERILE PRODUCT DO NOT RESTERILIZE 12/14 TAPER
• Type of Device: PROSTEHSIS, 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: 17254151
• MDR Text Key: 318360253
• Report Number: 0001822565-2023-01769
• Device Sequence Number: 1
• Product Code: LPH
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K953337
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Consumer,Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date: 02/13/2024

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: 12/31/2018
• Device Catalogue Number: 00801803202
• Device Lot Number: 61156942
• 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: 06/09/2023
• Initial Date FDA Received: 07/05/2023
• Supplement Dates Manufacturer Received: 07/26/2023; 09/12/2023
• Supplement Dates FDA Received: 08/02/2023; 10/03/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 12/22/2008
• 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: H10
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Sex: Male