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

Model Number N/A

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

Patient Problems Host-Tissue Reaction (1297); Inflammation (1932); Neurological Deficit/Dysfunction (1982); Pain (1994); Anxiety (2328); Shaking/Tremors (2515)

Event Date 05/16/2019

Event Type  Injury  

Manufacturer Narrative

(b)(4).Reported event was confirmed by review of medical records noting armd per mri results, hip pain with neurological cognitive decline, tremor, unaccustomed anxiety, brain scan shows hypometabolism consistent with chronic toxic encephalopathy.Head and trunnion showed moderate corrosive debris.Stem and cup were found to be well fixed and retained by the patient.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.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.Multiple mdr reports were filed for this event, please see associated reports: 0001822565-2019-04095.

Event Description

It was reported that patient underwent a left hip revision approximately 13 years post implantation due to elevated metal ion levels, pseudotumor, and pain.During the revision, moderate corrosive metal debris was found on the trunnion and head.The head, liner and neck components were removed and replaced.Attempts have been made and additional information on the reported event is unavailable at this time.

Manufacturer Narrative

This follow-up report is being submitted to relay additional information.Concomitant medical products: 00620006022 ¿ shell ¿ 60552505.00630506032 ¿ liner ¿ 60451566.00801803201 ¿ cocr head ¿ 60605039.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

It was reported that patient underwent a left hip revision approximately 13 years post implantation due to elevated metal ion levels, neurologic symptoms, pain and pseudotumor.During the procedure, moderate corrosive metal debris was found on the trunnion and head.The liner, head and neck were removed and replaced.Symptoms have been reported as improving post-op.Attempts have been made and additional information on the reported event is unavailable at this time.

Manufacturer Narrative

This follow-up report is being submitted to relay additional information.The following sections were updated/corrected updated: b5; e1; e4; g3; g4; h2; h3; h6 additional medical records were reviewed noting patient is experiencing improved elevated metal ion levels post operatively.Dhr was reviewed and no discrepancies were found.Additional information does not change the previous investigation.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.Multiple mdr reports were filed for this event, please see associated reports: 0002648920 - 2020 - 00174.

• Brand Name: FEMORAL STEM 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: 9103604
• MDR Text Key: 161841512
• Report Number: 0001822565-2019-04096
• Device Sequence Number: 1
• Product Code: LZO
• Combination Product (y/n): N
• PMA/PMN Number: K161830
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer,health professional
• Type of Report: Initial,Followup,Followup
• Report Date: 03/17/2020

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: 10/31/2015
• Device Model Number: N/A
• Device Catalogue Number: 00771101020
• Device Lot Number: 60374684
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 09/04/2019
• Initial Date FDA Received: 09/23/2019
• Supplement Dates Manufacturer Received: 12/03/2019; 03/11/2020
• Supplement Dates FDA Received: 12/26/2019; 03/17/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: N/A
• Patient Sequence Number: 1
• Treatment: UNK CUP; UNK HEAD; UNK LINER
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 67 YR
• Patient Weight: 98