MAUDE Adverse Event Report: ZIMMER BIOMET, INC. MODULAR NECK BB 12/14 NECK TAPER; PROSTHESIS HIP

Catalog Number 00784802201

Device Problems Corroded (1131); Material Erosion (1214)

Patient Problems Failure of Implant (1924); Pain (1994); Osteopenia/ Osteoporosis (2651); Metal Related Pathology (4530)

Event Date 07/23/2020

Event Type  Injury  

Manufacturer Narrative

(b)(4).Customer has indicated that the product will not be returned to zimmer biomet for investigation as the product location is unknown.The investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.Concomitant medical products: m/l taper femoral stem with kinectiv technology (00-7713-012-00, 61239540); kinectiv modular neck (00-7848-022-01, 61086270); versys femoral head +0 (00-8018-036-02, 61248219); tm modular acetabular cup (00-6202-058-22, 61083702); trilogy longevity acetabular liner (00-6310-058-36, 61181156).Multiple mdr reports were filed for this event, please see associated reports: 0002648920-2021-00326, 0002648920-2021-00325.

Event Description

It was reported that patient underwent a left hip revision surgery approximately 11 years post implantation due to dislocation, pain, instability, elevated metal ions.During the revision the surgeon reported metallosis, corrosion, liner fracture and wear.All components were removed.Attempts have been made and additional information on the reported event is unavailable at this time.

Event Description

No further event information available at the time of this report.

Manufacturer Narrative

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.10 years following the procedure, the patient had high cobalt levels.A revision was performed, for pain and a history of dislocation as well.There was metal corrosion found, and the stem was well fixed but removed by osteotomy that was later secured with cables.The liner showed wear and a fracture and the shell was removed when it was found to be well-fixed to increase stability.Zimmer biomet products were implanted.A metal ion test showed the cobalt level to be 0.6, which is still high but lower than the level found previously.Device history record (dhr) was reviewed and no discrepancies were found.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: MODULAR NECK BB 12/14 NECK TAPER
• Type of Device: PROSTHESIS HIP
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 56 e. bell drive; warsaw IN 46582
• MDR Report Key: 12589285
• MDR Text Key: 275132898
• Report Number: 0001822565-2021-02881
• Device Sequence Number: 1
• Product Code: LZO
• Combination Product (y/n): N
• PMA/PMN Number: K182678
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer,distributor,health p
• Type of Report: Initial,Followup
• Report Date: 10/28/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/07/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 09/30/2018
• Device Catalogue Number: 00784802201
• Device Lot Number: 61086270
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 10/27/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: SEE H10
• Patient Outcome(s): Hospitalization; Required Intervention