MAUDE Adverse Event Report: ZIMMER BIOMET, INC. FEMORAL STEM BEADED MIDCOAT 12/14 NECK TAPER; PROSTHESIS, HIP

Catalog Number 00784701100

Device Problems Material Erosion (1214); Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Bone Fracture(s) (1870); Failure of Implant (1924); Muscle Weakness (1967); Pain (1994); Shock (2072); Blurred Vision (2137); Visual Impairment (2138); Anxiety (2328); Depression (2361); Osteopenia/ Osteoporosis (2651); Unspecified Mental, Emotional or Behavioural Problem (4430); Metal Related Pathology (4530)

Event Date 11/03/2020

Event Type  Injury  

Manufacturer Narrative

(b)(4).Report source: canada.Multiple mdr reports were filed for this event, please see associated reports: 0001822565-2022-03458.(b)(4).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.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

It was reported that a patient underwent a left hip revision approximately twelve years post implantation due to elevated ion levels and vision impairment.Attempts have been made and no further information is available.

Event Description

It was reported that a patient underwent a left hip revision approximately twelve years post implantation due to rapid vision loss and elevated cobalt levels.During the procedure, metal debris was irrigated from the joint.While removing the stem, a cerclage wire was placed prior to removal, however a longitudinal fracture still occurred as the bone was fairly thin and the stem was well ingrown.The site was preserved and stabilized with cerclage wire and bone putty after the new stem was successfully placed.The initial cup remained intact and the other components were removed and replaced.

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.

Manufacturer Narrative

(b)(4).Dhr was reviewed and no discrepancies related to the reported event were found.Medical records were provided and reviewed by a health care professional.Review of the available records identified the following: an initial left tha was performed on (b)(6) 2008.The patient presented with rapid vision loss and elevated metal ions was identified from blood testing.A revision occurred on (b)(6) 2020, where the head, stem, and liner were revised.While removing the stem, a fracture occurred and cables were placed.The remaining cobalt particles were removed.The complaint was confirmed based on the provided medical records.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.

Event Description

No additional event information to report at this time.

• Brand Name: FEMORAL STEM BEADED MIDCOAT 12/14 NECK TAPER
• 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: 16006075
• MDR Text Key: 305722873
• Report Number: 0001822565-2022-03457
• Device Sequence Number: 1
• Product Code: LPH
• Combination Product (y/n): N
• Reporter Country Code: CA
• PMA/PMN Number: K953337
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Consumer,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date: 02/22/2024

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: 10/31/2013
• Device Catalogue Number: 00784701100
• Device Lot Number: 60077886
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 11/22/2022
• Initial Date FDA Received: 12/19/2022
• Supplement Dates Manufacturer Received: 10/13/2023; 02/19/2024
• Supplement Dates FDA Received: 11/07/2023; 02/22/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 10/17/2003
• 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: UNK ZIMMER TRILOGY CUP; UNK ZIMMER TRILOGY LINER; UNK ZIMMER VERSYS HEAD
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Sex: Female