MAUDE Adverse Event Report: ZIMMER BIOMET, INC. M/L TAPER FEMORAL STEM; PROSTHESIS, HIP

Model Number N/A

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

Patient Problems Host-Tissue Reaction (1297); Local Reaction (2035)

Event Date 08/25/2016

Event Type  Injury  

Manufacturer Narrative

(b)(4).Concomitant medical products: 00801803601, cocr head, 60900927.00631006036, xlpe liner, 61112331.00620006022, shell, 61157327.00625006525, bone screw, 61159884.Customer has indicated that the product will not be returned to zimmer biomet as the product location is unknown.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 - 00264, 0002648920 - 2020 - 00300.

Event Description

It was reported that patient underwent a right hip revision approximately 8 years post implantation due to elevated metal ion levels and poly wear.During the surgery, corrosion was found along the entire trunnion of the stem.Thickening of the pseudocapsule was found and debrided.Attempts have been made and additional information on the reported event is unavailable at this time.

Manufacturer Narrative

Reported event was confirmed by review of medical records noting patient was experiencing elevated metal ion levels, the liner was showing signs of wear and corrosion.During the procedure, there was cloudy joint fluid and negative gram stains noted.There were scratches on the poly but no metal debris embedded.Corrosion stamping and discoloration along the trunnion, black material at the neck consistent with fretting/corrosion debris and debris noted within the head ring.The trunnion was cleaned and remained implanted.Pseudocapsule was noted as thickened and was debrided.Dhr was reviewed and no discrepancies were found.The root cause is 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.

Event Description

No additional event information to report at this time.

• Brand Name: M/L TAPER FEMORAL STEM
• Type of Device: PROSTHESIS, HIP
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 56 e. bell drive; warsaw IN 46582
• MDR Report Key: 10151502
• MDR Text Key: 197086682
• Report Number: 0001822565-2020-02073
• Device Sequence Number: 1
• Product Code: LZO
• Combination Product (y/n): N
• PMA/PMN Number: K192660
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer,health professional
• Type of Report: Initial,Followup
• Report Date: 08/20/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/14/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 10/31/2018
• Device Model Number: N/A
• Device Catalogue Number: 00771101500
• Device Lot Number: 61070690
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 08/19/2020
• 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