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

Model Number N/A

Device Problems Corroded (1131); Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Pain (1994); Synovitis (2094); No Code Available (3191)

Event Date 01/16/2019

Event Type  Injury  

Manufacturer Narrative

(b)(4).Concomitant medical products: 00784800200 ¿ m/l taper neck ¿ 60987252.00801803202 ¿ cocr head ¿ 61074126.00620206022 ¿ trabecular metal shell ¿ 60592623.00625006525 ¿ bone screw ¿ 61110831.00630506040 ¿ xlpe liner ¿ 60866512.Customer has indicated that the product will not be returned to zimmer biomet for the 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.Multiple mdr reports were filed for this event, please see associated reports: 0001822565 - 2020 - 02288.0002648920 - 2020 - 00324.0001822565 - 2020 - 02290.0001822565 - 2020 - 02291.

Event Description

It was reported that patient underwent a right hip revision approximately 10 years post implantation due to experiencing multiple dislocations, instability, pain and malpositioning of the shell component.During the procedure, mild synovitis and corrosion of the trunnion was found.All 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.The following sections were updated/corrected.Updated: g4; h2; h3; h6.Corrected: h6 patient and device codes.Reported event was confirmed by review of medical records noting the patient experienced dislocation, instability, pain and it is.Radiology reported recurring dislocations after a fall and bending forwards.The shell was retroverted.Mild synovitis and corrosion on the trunnion was also noted.Dhr was reviewed and no discrepancies were found.A definitive root cause cannot be determined, however it was reported the patient experienced at least one fall, which may have contributed to the reported event.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 STEM
• Type of Device: PROSTHESIS, HIP
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 56 e. bell drive; warsaw IN 46582
• MDR Report Key: 10205751
• MDR Text Key: 197012171
• Report Number: 0001822565-2020-02289
• Device Sequence Number: 1
• Product Code: LPH
• 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,health professional
• Type of Report: Initial,Followup
• Report Date: 08/10/2020

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: 10/31/2017
• Device Model Number: N/A
• Device Catalogue Number: 00771301600
• Device Lot Number: 60796234
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 06/04/2020
• Initial Date FDA Received: 06/29/2020
• Supplement Dates Manufacturer Received: 08/05/2020
• Supplement Dates FDA Received: 08/10/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: N/A
• Patient Sequence Number: 1
• Treatment: SEE H10.
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Weight: 89