MAUDE Adverse Event Report: ZIMMER BIOMET, INC. FEMORAL STEM 12/14 NECK TAPER SIZE 11 STANDARD OFFSET; PROSTHESIS, HIP

Model Number N/A

Device Problems Corroded (1131); Material Erosion (1214); Insufficient Information (3190)

Patient Problems Host-Tissue Reaction (1297); Pain (1994); No Information (3190)

Event Date 09/18/2018

Event Type  Injury  

Manufacturer Narrative

(b)(4).Concomitant medical product(s): 00801803602 femoral head 61357236; 00875101336 liner neutral 36 mm 61303880; 00875705802 shell with multi holes 61321986; 00625006530 bone scr 61341911; 00625006535 bone scr 61341914.Customer has indicated that the product will not be returned to zimmer biomet for investigation.The product remains implanted.The investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.Multiple mdr reports were filed for this event, please see associated reports: 0002648920 - 2020 - 00209 head.

Event Description

It was reported that the patient underwent left total hip arthroplasty and was later revised nine years later due to unknown reasons.The femoral head was exchanged.Attempts have been made and no further information has been provided.

Manufacturer Narrative

(b)(6).Reported event was confirmed by review of medical records.Device history record (dhr) was reviewed and no discrepancies were found.Root cause was unable to be determined.Medical records identified the following : patient underwent a revision procedure on due to elevated metal ions, pain, corrosion, and pseudotumor.Blood work showed that patient had elevated meta ions.Post revision blood work showed a reduction in the metal ion levels during the revision procedure, corrosion was noted at the head/ neck junction.Pseudotumor was observed in the joint space.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 further event information available at the time of this report.

Manufacturer Narrative

(b)(4) this follow-up report is being submitted to relay additional information.Updated: a1, a2, a6, b4, b5, b6, g4, h2, h3, h6 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 the patient underwent left total hip arthroplasty and was later revised nine years later due to left hip pain, elevated metal ions, corrosion and pseudotumor.Attempts have been made and no further information has been provided.

Event Description

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

Manufacturer Narrative

(b)(4).This follow-up report is being submitted to relay additional information.Updated: a4, b4, b5, b7, g4, h2 corrected: e1 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 further event information available at the time of this report.

Manufacturer Narrative

(b)(4).Reported event was confirmed by review of medical records.Device history record (dhr) was reviewed and no discrepancies were found.Root cause was unable to be determined.The received additional information does not change the final results of previous investigation.If any further information is found which would change or alter any conclusions or information, a supplemental report will be filed accordingly.Zimmer biomet will continue to monitor for trends.

• Brand Name: FEMORAL STEM 12/14 NECK TAPER SIZE 11 STANDARD OFFSET
• Type of Device: PROSTHESIS, HIP
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 56 e. bell drive; warsaw IN 46582
• MDR Report Key: 9900801
• MDR Text Key: 191866121
• Report Number: 0001822565-2020-01113
• 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,distributor,health p
• Type of Report: Initial,Followup,Followup,Followup,Followup
• Report Date: 08/28/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/30/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 07/31/2019
• Device Model Number: N/A
• Device Catalogue Number: 00771101100
• Device Lot Number: 61273064
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 08/27/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: N/A
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Weight: 107